Trial Outcomes & Findings for Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) (NCT NCT04283461)
NCT ID: NCT04283461
Last Updated: 2024-03-18
Results Overview
Number of participants that experienced any MAAEs from Day 1 to Day 394.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
Day 1 to Day 394
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 and met all eligibility criteria. Participants were recruited from the community surrounding the clinical sites. Enrollment occurred between 16MAR2020 and 17JUNE2020.
Participant milestones
| Measure |
10 mcg of mRNA-1273: 18-55 Years
10 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 18-55 Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273:18-55 Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 18-55 Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 18-55 Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 56-70 Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273: 56-70 Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 56-70 Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 56-70 Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 71+ Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273: 71+ Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 71+ Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 71+ Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
15
|
15
|
15
|
15
|
10
|
10
|
10
|
0
|
10
|
10
|
10
|
0
|
|
Overall Study
COMPLETED
|
0
|
15
|
7
|
2
|
3
|
10
|
10
|
2
|
0
|
10
|
10
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
8
|
13
|
12
|
0
|
0
|
8
|
0
|
0
|
0
|
7
|
0
|
Reasons for withdrawal
| Measure |
10 mcg of mRNA-1273: 18-55 Years
10 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 18-55 Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273:18-55 Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 18-55 Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 18-55 Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 56-70 Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273: 56-70 Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 56-70 Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 56-70 Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
25 mcg of mRNA-1273: 71+ Years
25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
50 mcg of mRNA-1273: 71+ Years
50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
100 mcg of mRNA-1273: 71+ Years
100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
250 mcg of mRNA-1273: 71+ Years
250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Enrolled in separate trial
|
0
|
0
|
8
|
13
|
12
|
0
|
0
|
8
|
0
|
0
|
0
|
7
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)
Baseline characteristics by cohort
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 8.0 • n=93 Participants
|
36.5 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
30.8 years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
30.4 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
65.4 years
STANDARD_DEVIATION 4.6 • n=36 Participants
|
61.6 years
STANDARD_DEVIATION 3.7 • n=10 Participants
|
63.3 years
STANDARD_DEVIATION 4.2 • n=115 Participants
|
72.3 years
STANDARD_DEVIATION 1.3 • n=40 Participants
|
74.7 years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
72.2 years
STANDARD_DEVIATION 1.2 • n=62 Participants
|
51.3 years
STANDARD_DEVIATION 19.0 • n=95 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
59 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
61 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
9 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
10 Participants
n=62 Participants
|
111 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=62 Participants
|
109 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
15 participants
n=27 Participants
|
15 participants
n=483 Participants
|
10 participants
n=36 Participants
|
10 participants
n=10 Participants
|
10 participants
n=115 Participants
|
10 participants
n=40 Participants
|
10 participants
n=8 Participants
|
10 participants
n=62 Participants
|
120 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 394Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants that experienced any MAAEs from Day 1 to Day 394.
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Medically-attended Adverse Events (MAAEs)
|
7 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 394Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants that experienced any NOCMCs from Day 1 to Day 394.
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 394Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
The number of participants that experience any SAEs from Day 1 to Day 394. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Through 7 days post-vaccinationPopulation: The Safety Analysis population for the main study 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 |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Solicited Reactogenicity Adverse Events (AEs)
Local Events
|
11 participants
|
14 participants
|
15 participants
|
15 participants
|
8 participants
|
9 participants
|
9 participants
|
8 participants
|
7 participants
|
10 participants
|
|
Frequency of Solicited Reactogenicity Adverse Events (AEs)
Systemic Events
|
8 participants
|
13 participants
|
15 participants
|
15 participants
|
8 participants
|
6 participants
|
8 participants
|
5 participants
|
6 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Through 28 days post-vaccinationPopulation: The Safety Analysis population for the main study 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 |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Not Related : Mild
|
28 events
|
22 events
|
15 events
|
16 events
|
9 events
|
6 events
|
5 events
|
18 events
|
8 events
|
26 events
|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Not Related : Moderate
|
3 events
|
7 events
|
6 events
|
14 events
|
7 events
|
4 events
|
7 events
|
5 events
|
6 events
|
4 events
|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Not Related : Severe
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
1 events
|
0 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Related : Mild
|
4 events
|
5 events
|
10 events
|
11 events
|
2 events
|
0 events
|
1 events
|
12 events
|
2 events
|
3 events
|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Related : Moderate
|
1 events
|
1 events
|
3 events
|
7 events
|
2 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Related : Severe
|
0 events
|
0 events
|
0 events
|
3 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Through 28 days post-vaccinationPopulation: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of any unsolicited AEs through 28 days post vaccination by severity
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Grade of Any Unsolicited Adverse Events (AEs)
Mild
|
32 events
|
27 events
|
25 events
|
27 events
|
11 events
|
6 events
|
6 events
|
30 events
|
10 events
|
29 events
|
|
Grade of Any Unsolicited Adverse Events (AEs)
Moderate
|
4 events
|
8 events
|
9 events
|
21 events
|
9 events
|
5 events
|
7 events
|
5 events
|
6 events
|
4 events
|
|
Grade of Any Unsolicited Adverse Events (AEs)
Severe
|
0 events
|
0 events
|
0 events
|
4 events
|
0 events
|
1 events
|
1 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Through 7 days post vaccinationPopulation: The Safety Analysis population for the main study 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 |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 1 · Moderate
|
2 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 1 · None
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 1 · Mild
|
8 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 1 · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 2 · None
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 2 · Mild
|
7 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 2 · Moderate
|
3 Participants
|
7 Participants
|
11 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Dose 2 · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 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 fold rise (GMFR) in IgG ELISA titer from baseline against RBD. Fold-rise is calculated by dividing post-vaccination results by the baseline value.
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 15
|
118.232 Fold Rise
Interval 60.888 to 229.579
|
46.423 Fold Rise
Interval 24.502 to 87.956
|
205.148 Fold Rise
Interval 105.848 to 397.603
|
151.985 Fold Rise
Interval 74.288 to 310.944
|
14.358 Fold Rise
Interval 2.731 to 75.481
|
24.082 Fold Rise
Interval 12.174 to 47.639
|
138.867 Fold Rise
Interval 47.29 to 407.785
|
42.034 Fold Rise
Interval 14.335 to 123.258
|
11.013 Fold Rise
Interval 2.664 to 45.534
|
51.027 Fold Rise
Interval 17.037 to 152.833
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 29
|
326.688 Fold Rise
Interval 194.477 to 548.78
|
113.292 Fold Rise
Interval 51.591 to 248.785
|
561.479 Fold Rise
Interval 264.946 to 1189.896
|
222.148 Fold Rise
Interval 107.069 to 460.915
|
23.779 Fold Rise
Interval 5.816 to 97.219
|
38.967 Fold Rise
Interval 19.884 to 76.363
|
204.880 Fold Rise
Interval 54.672 to 767.772
|
137.911 Fold Rise
Interval 37.221 to 510.994
|
42.530 Fold Rise
Interval 11.332 to 159.622
|
112.047 Fold Rise
Interval 39.432 to 318.385
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 36
|
2621.803 Fold Rise
Interval 1355.412 to 5071.41
|
1122.191 Fold Rise
Interval 669.513 to 1880.939
|
3007.923 Fold Rise
Interval 1610.324 to 5618.496
|
1086.092 Fold Rise
Interval 554.012 to 2129.187
|
975.663 Fold Rise
Interval 330.19 to 2882.945
|
303.529 Fold Rise
Interval 136.134 to 676.756
|
4418.756 Fold Rise
Interval 1818.818 to 10735.216
|
1443.444 Fold Rise
Interval 386.453 to 5391.417
|
407.474 Fold Rise
Interval 109.921 to 1510.502
|
1414.165 Fold Rise
Interval 487.854 to 4099.307
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 43
|
2734.849 Fold Rise
Interval 1338.67 to 5587.186
|
1073.107 Fold Rise
Interval 726.428 to 1585.232
|
3527.768 Fold Rise
Interval 1637.665 to 7599.321
|
941.022 Fold Rise
Interval 437.492 to 2024.092
|
989.692 Fold Rise
Interval 411.218 to 2381.921
|
701.940 Fold Rise
Interval 272.166 to 1810.366
|
3071.850 Fold Rise
Interval 1480.126 to 6375.312
|
2653.994 Fold Rise
Interval 759.931 to 9268.852
|
657.204 Fold Rise
Interval 173.073 to 2495.569
|
1380.702 Fold Rise
Interval 475.775 to 4006.81
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 57
|
2427.728 Fold Rise
Interval 1238.979 to 4757.03
|
877.135 Fold Rise
Interval 557.842 to 1379.184
|
2343.458 Fold Rise
Interval 963.83 to 5697.89
|
839.589 Fold Rise
Interval 364.917 to 1931.696
|
383.266 Fold Rise
Interval 156.92 to 936.101
|
578.229 Fold Rise
Interval 249.207 to 1341.649
|
1611.388 Fold Rise
Interval 367.006 to 7075.003
|
1962.908 Fold Rise
Interval 480.835 to 8013.154
|
626.325 Fold Rise
Interval 180.467 to 2173.714
|
901.571 Fold Rise
Interval 270.733 to 3002.336
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 119
|
1707.917 Fold Rise
Interval 793.649 to 3675.4
|
195.764 Fold Rise
Interval 117.352 to 326.571
|
1416.229 Fold Rise
Interval 684.896 to 2928.48
|
346.524 Fold Rise
Interval 164.75 to 728.856
|
223.100 Fold Rise
Interval 82.918 to 600.274
|
154.917 Fold Rise
Interval 61.416 to 390.765
|
463.340 Fold Rise
Interval 141.681 to 1515.262
|
593.198 Fold Rise
Interval 150.885 to 2332.137
|
187.845 Fold Rise
Interval 59.459 to 593.45
|
313.979 Fold Rise
Interval 88.41 to 1115.058
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 209
|
368.468 Fold Rise
Interval 187.618 to 723.644
|
40.957 Fold Rise
Interval 23.071 to 72.712
|
556.673 Fold Rise
Interval 290.404 to 1067.082
|
91.215 Fold Rise
Interval 44.456 to 187.154
|
100.000 Fold Rise
Interval 33.5 to 298.509
|
285.832 Fold Rise
Interval 140.919 to 579.766
|
181.844 Fold Rise
Interval 55.959 to 590.924
|
201.187 Fold Rise
Interval 52.192 to 775.526
|
475.445 Fold Rise
Interval 153.101 to 1476.465
|
91.951 Fold Rise
Interval 27.684 to 305.406
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Day 394
|
727.556 Fold Rise
Interval 399.079 to 1326.4
|
190.546 Fold Rise
Interval 51.219 to 708.876
|
441.135 Fold Rise
Interval 110.864 to 1755.303
|
61.113 Fold Rise
Interval 31.403 to 118.932
|
79.878 Fold Rise
Interval 11.702 to 545.251
|
114.078 Fold Rise
Interval 31.552 to 412.448
|
183.781 Fold Rise
Interval 39.49 to 855.284
|
285.957 Fold Rise
Interval 31.077 to 2631.214
|
451.648 Fold Rise
Interval 113.72 to 1793.75
|
110.892 Fold Rise
Interval 26.367 to 466.386
|
SECONDARY outcome
Timeframe: Day 1 to 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 fold rise (GMFR) in IgG titer from baseline against S-2P (Wa-1). Fold-rise is calculated by dividing post-vaccination results by the baseline value.
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 15
|
278.826 Fold Rise
Interval 120.686 to 644.185
|
190.575 Fold Rise
Interval 92.86 to 391.117
|
656.649 Fold Rise
Interval 327.031 to 1318.492
|
915.658 Fold Rise
Interval 418.876 to 2001.617
|
55.693 Fold Rise
Interval 9.591 to 323.405
|
78.037 Fold Rise
Interval 39.479 to 154.251
|
84.723 Fold Rise
Interval 33.765 to 212.586
|
133.721 Fold Rise
Interval 54.358 to 328.953
|
20.706 Fold Rise
Interval 6.404 to 66.946
|
109.977 Fold Rise
Interval 31.717 to 381.332
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 57
|
1976.059 Fold Rise
Interval 982.475 to 3974.462
|
1588.791 Fold Rise
Interval 666.141 to 3789.374
|
6157.842 Fold Rise
Interval 3199.803 to 11850.426
|
6479.378 Fold Rise
Interval 2562.589 to 16382.782
|
1715.932 Fold Rise
Interval 428.208 to 6876.149
|
559.114 Fold Rise
Interval 319.663 to 977.93
|
1393.157 Fold Rise
Interval 251.085 to 7729.989
|
10169.509 Fold Rise
Interval 3720.365 to 27798.057
|
483.727 Fold Rise
Interval 164.214 to 1424.92
|
3815.048 Fold Rise
Interval 1262.647 to 11527.051
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 119
|
1964.265 Fold Rise
Interval 1092.299 to 3532.306
|
511.132 Fold Rise
Interval 162.699 to 1605.762
|
3148.715 Fold Rise
Interval 1628.418 to 6088.368
|
3190.558 Fold Rise
Interval 1258.565 to 8088.311
|
457.931 Fold Rise
Interval 131.073 to 1599.876
|
134.834 Fold Rise
Interval 68.773 to 264.353
|
385.745 Fold Rise
Interval 95.962 to 1550.604
|
682.182 Fold Rise
Interval 271.806 to 1712.148
|
184.289 Fold Rise
Interval 51.001 to 665.918
|
204.739 Fold Rise
Interval 102.957 to 407.139
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 209
|
532.926 Fold Rise
Interval 259.219 to 1095.636
|
349.194 Fold Rise
Interval 133.31 to 914.681
|
639.244 Fold Rise
Interval 330.763 to 1235.426
|
391.021 Fold Rise
Interval 164.947 to 926.949
|
149.796 Fold Rise
Interval 41.609 to 539.277
|
127.513 Fold Rise
Interval 64.754 to 251.097
|
131.644 Fold Rise
Interval 31.225 to 554.998
|
374.024 Fold Rise
Interval 148.317 to 943.21
|
193.464 Fold Rise
Interval 64.217 to 582.841
|
114.639 Fold Rise
Interval 42.789 to 307.141
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 394
|
467.448 Fold Rise
Interval 196.093 to 1114.309
|
426.170 Fold Rise
Interval 157.075 to 1156.273
|
1079.124 Fold Rise
Interval 360.017 to 3234.598
|
650.429 Fold Rise
Interval 219.338 to 1928.793
|
217.986 Fold Rise
Interval 25.301 to 1878.122
|
214.487 Fold Rise
Interval 53.375 to 861.917
|
258.048 Fold Rise
Interval 80.107 to 831.244
|
824.518 Fold Rise
Interval 106.753 to 6368.232
|
824.138 Fold Rise
Interval 160.041 to 4243.928
|
50.304 Fold Rise
Interval 22.538 to 112.273
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 29
|
347.590 Fold Rise
Interval 170.815 to 707.305
|
334.452 Fold Rise
Interval 129.835 to 861.536
|
830.870 Fold Rise
Interval 379.34 to 1819.858
|
1259.340 Fold Rise
Interval 532.93 to 2975.879
|
93.735 Fold Rise
Interval 16.091 to 546.028
|
79.671 Fold Rise
Interval 35.902 to 176.798
|
176.685 Fold Rise
Interval 61.056 to 511.295
|
522.637 Fold Rise
Interval 177.45 to 1539.307
|
49.900 Fold Rise
Interval 15.513 to 160.514
|
213.206 Fold Rise
Interval 102.237 to 444.622
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 36
|
2497.277 Fold Rise
Interval 1278.098 to 4879.431
|
2450.191 Fold Rise
Interval 828.251 to 7248.329
|
5943.834 Fold Rise
Interval 2823.63 to 12511.967
|
6601.865 Fold Rise
Interval 2948.586 to 14781.533
|
1662.647 Fold Rise
Interval 446.013 to 6198.01
|
358.509 Fold Rise
Interval 157.061 to 818.338
|
4779.693 Fold Rise
Interval 543.021 to 42071.027
|
4145.720 Fold Rise
Interval 1610.338 to 10672.911
|
297.577 Fold Rise
Interval 97.44 to 908.791
|
2765.031 Fold Rise
Interval 796.46 to 9599.223
|
|
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Day 43
|
2425.121 Fold Rise
Interval 1306.938 to 4499.992
|
2512.713 Fold Rise
Interval 1008.639 to 6259.647
|
6380.536 Fold Rise
Interval 2845.471 to 14307.382
|
5007.258 Fold Rise
Interval 2114.555 to 11857.17
|
2523.481 Fold Rise
Interval 856.05 to 7438.764
|
744.903 Fold Rise
Interval 390.71 to 1420.187
|
1548.460 Fold Rise
Interval 315.724 to 7594.384
|
2737.159 Fold Rise
Interval 913.784 to 8198.917
|
774.819 Fold Rise
Interval 213.61 to 2810.468
|
8483.987 Fold Rise
Interval 2252.065 to 31960.904
|
SECONDARY outcome
Timeframe: Day 1 to 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 RBD
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 209
|
20464.446 Titer
Interval 10276.948 to 40750.773
|
24084.261 Titer
Interval 14896.24 to 38939.467
|
92441.432 Titer
Interval 57141.666 to 149547.939
|
52496.861 Titer
Interval 34936.109 to 78884.582
|
20361.042 Titer
Interval 9275.521 to 44695.28
|
123784.614 Titer
Interval 69755.695 to 219661.357
|
40560.192 Titer
Interval 13771.075 to 119462.654
|
22376.904 Titer
Interval 11234.479 to 44570.454
|
92150.989 Titer
Interval 35818.319 to 237079.938
|
49367.876 Titer
Interval 25170.231 to 96828.163
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 1
|
55.539 Titer
Interval 44.34 to 69.567
|
588.031 Titer
Interval 411.408 to 840.48
|
166.061 Titer
Interval 81.76 to 337.282
|
575.528 Titer
Interval 349.084 to 948.863
|
203.610 Titer
Interval 113.648 to 364.785
|
348.980 Titer
Interval 165.342 to 736.573
|
223.049 Titer
Interval 64.175 to 775.238
|
111.224 Titer
Interval 45.771 to 270.276
|
193.821 Titer
Interval 92.028 to 408.205
|
503.037 Titer
Interval 174.025 to 1454.084
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 36
|
145612.950 Titer
Interval 77796.145 to 272547.326
|
659882.584 Titer
Interval 466389.271 to 933651.463
|
499497.517 Titer
Interval 400839.447 to 622438.163
|
625076.733 Titer
Interval 437605.395 to 892861.3
|
198655.229 Titer
Interval 98717.264 to 399766.951
|
105925.373 Titer
Interval 50971.843 to 220125.148
|
985598.423 Titer
Interval 284610.485 to 3413100.72
|
160546.189 Titer
Interval 82581.2 to 312117.997
|
78976.885 Titer
Interval 25690.683 to 242786.399
|
711377.295 Titer
Interval 368425.491 to 1373568.519
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 43
|
151891.452 Titer
Interval 74930.671 to 307898.124
|
572701.831 Titer
Interval 398614.411 to 822818.689
|
558929.643 Titer
Interval 462950.139 to 674807.758
|
541585.049 Titer
Interval 347184.872 to 844836.25
|
201511.576 Titer
Interval 115921.617 to 350296.315
|
244962.722 Titer
Interval 154477.301 to 388450.181
|
685172.620 Titer
Interval 222613.551 to 2108863.173
|
295188.885 Titer
Interval 167304.797 to 520824.741
|
127379.635 Titer
Interval 44079.97 to 368093.979
|
694544.378 Titer
Interval 465009.324 to 1037381.118
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 57
|
134834.181 Titer
Interval 70747.115 to 256975.23
|
515782.576 Titer
Interval 328490.907 to 809860.058
|
371290.883 Titer
Interval 266713.944 to 516871.813
|
483207.129 Titer
Interval 303572.459 to 769138.051
|
78036.898 Titer
Interval 42855.978 to 142098.203
|
201790.167 Titer
Interval 135955.705 to 299503.957
|
359418.146 Titer
Interval 128908.94 to 1002113.613
|
218323.256 Titer
Interval 106760.447 to 446467.258
|
121394.777 Titer
Interval 43523.048 to 338595.123
|
453523.713 Titer
Interval 255612.038 to 804671.643
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 394
|
40407.936 Titer
Interval 23427.721 to 69695.268
|
90573.260 Titer
Interval 27756.903 to 295548.658
|
70794.578 Titer
Interval 30435.905 to 164669.732
|
35172.238 Titer
Interval 20744.761 to 59633.674
|
12844.414 Titer
Interval 3233.887 to 51015.689
|
39810.717 Titer
Interval 17869.264 to 88693.813
|
40992.084 Titer
Interval 14189.286 to 118423.929
|
31805.337 Titer
Interval 4545.268 to 222556.593
|
87538.681 Titer
Interval 35329.764 to 216899.856
|
55782.760 Titer
Interval 13635.712 to 228203.428
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 119
|
94856.406 Titer
Interval 44231.293 to 203424.707
|
115115.375 Titer
Interval 75506.457 to 175502.205
|
235179.791 Titer
Interval 177210.044 to 312112.863
|
199434.367 Titer
Interval 127702.777 to 311458.121
|
45425.530 Titer
Interval 23050.545 to 89519.739
|
54062.982 Titer
Interval 36881.823 to 79247.873
|
103347.506 Titer
Interval 38416.686 to 278022.601
|
65978.130 Titer
Interval 33230.207 to 130998.691
|
36408.266 Titer
Interval 15287.605 to 86708.273
|
157942.861 Titer
Interval 94323.027 to 264473.564
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 15
|
6566.491 Titer
Interval 3650.209 to 11812.694
|
27298.157 Titer
Interval 15906.715 to 46847.473
|
34066.956 Titer
Interval 21684.705 to 53519.636
|
87471.519 Titer
Interval 51857.424 to 147544.285
|
2923.479 Titer
Interval 576.391 to 14828.01
|
8404.270 Titer
Interval 5860.592 to 12051.983
|
30974.193 Titer
Interval 15895.84 to 60355.452
|
4675.198 Titer
Interval 2235.438 to 9777.713
|
2134.519 Titer
Interval 513.626 to 8870.598
|
25668.471 Titer
Interval 12391.568 to 53170.866
|
|
Geometric Mean Titer (GMT) of Antibody Against RBD
Day 29
|
18144.012 Titer
Interval 11088.17 to 29689.766
|
66619.290 Titer
Interval 35965.306 to 123400.305
|
93239.514 Titer
Interval 59894.633 to 145148.347
|
120088.107 Titer
Interval 71026.274 to 203039.702
|
4841.724 Titer
Interval 1531.597 to 15305.782
|
13598.782 Titer
Interval 7948.752 to 23264.892
|
45698.295 Titer
Interval 26323.563 to 79333.264
|
15339.104 Titer
Interval 7087.422 to 33197.985
|
8243.279 Titer
Interval 2486.083 to 27332.811
|
56363.766 Titer
Interval 35061.83 to 90607.766
|
SECONDARY outcome
Timeframe: Day 1 to 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 S-2P (Wa-1)
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 29
|
40216.104 Titer
Interval 29088.696 to 55600.122
|
118304.156 Titer
Interval 71951.24 to 194518.861
|
109211.071 Titer
Interval 79048.399 to 150882.981
|
213515.089 Titer
Interval 128810.327 to 353921.103
|
17688.866 Titer
Interval 5303.052 to 59003.006
|
44884.873 Titer
Interval 23416.011 to 86037.364
|
115824.384 Titer
Interval 73271.749 to 183089.502
|
57982.909 Titer
Interval 31454.265 to 106885.911
|
16195.710 Titer
Interval 5218.359 to 50265.04
|
203329.316 Titer
Interval 97384.457 to 424531.922
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 1
|
115.700 Titer
Interval 71.727 to 186.63
|
353.726 Titer
Interval 132.208 to 946.402
|
131.442 Titer
Interval 64.973 to 265.91
|
178.484 Titer
Interval 81.254 to 392.061
|
188.712 Titer
Interval 76.456 to 465.788
|
563.378 Titer
Interval 315.579 to 1005.753
|
655.541 Titer
Interval 270.066 to 1591.222
|
110.943 Titer
Interval 55.418 to 222.1
|
324.564 Titer
Interval 103.755 to 1015.294
|
953.674 Titer
Interval 493.489 to 1842.99
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 15
|
32260.171 Titer
Interval 18721.778 to 55588.665
|
67411.398 Titer
Interval 32440.518 to 140080.89
|
86311.103 Titer
Interval 56413.13 to 132054.478
|
163430.584 Titer
Interval 102144.589 to 261487.722
|
10509.934 Titer
Interval 2841.259 to 38876.682
|
43964.284 Titer
Interval 20823.983 to 92818.854
|
55539.249 Titer
Interval 40604.778 to 75966.629
|
14835.425 Titer
Interval 6923.655 to 31788.101
|
6720.475 Titer
Interval 1734.084 to 26045.329
|
104881.768 Titer
Interval 22438.517 to 490236.733
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 36
|
288934.898 Titer
Interval 166075.942 to 502681.932
|
866695.749 Titer
Interval 641509.478 to 1170928.175
|
781267.935 Titer
Interval 606074.064 to 1007103.952
|
1178329.272 Titer
Interval 889033.807 to 1561762.739
|
313761.751 Titer
Interval 160505.758 to 613351.431
|
201976.108 Titer
Interval 99730.675 to 409045.145
|
3133285.724 Titer
Interval 570561.057 to 17206711.371
|
459938.749 Titer
Interval 272869.372 to 775256.128
|
96582.846 Titer
Interval 39661.176 to 235198.426
|
2636938.493 Titer
Interval 1072568.674 to 6482983.127
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 43
|
280586.432 Titer
Interval 167983.735 to 468668.862
|
734030.804 Titer
Interval 588265.571 to 915914.933
|
811094.448 Titer
Interval 656186.213 to 1002572.427
|
893716.961 Titer
Interval 661380.499 to 1207670.935
|
476211.633 Titer
Interval 264023.482 to 858929.354
|
419662.342 Titer
Interval 303128.058 to 580996.964
|
1015079.367 Titer
Interval 408139.653 to 2524592.041
|
303668.679 Titer
Interval 167756.794 to 549692.591
|
251478.001 Titer
Interval 119947.76 to 527239.4
|
8090958.992 Titer
Interval 2546021.264 to 25712125.163
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 57
|
228630.062 Titer
Interval 134203.687 to 389495.298
|
561996.141 Titer
Interval 407302.734 to 775442.039
|
782785.653 Titer
Interval 619387.634 to 989289.008
|
1156467.236 Titer
Interval 859119.097 to 1556729.996
|
323817.265 Titer
Interval 182136.112 to 575710.221
|
314992.345 Titer
Interval 217858.591 to 455433.854
|
913271.700 Titer
Interval 287340.911 to 2902702.559
|
1128236.122 Titer
Interval 635868.259 to 2001856.089
|
157000.126 Titer
Interval 81997.547 to 300607.036
|
3638312.512 Titer
Interval 1315790.941 to 10060350.416
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 119
|
227265.406 Titer
Interval 137995.234 to 374285.134
|
180800.655 Titer
Interval 109897.259 to 297449.43
|
413872.592 Titer
Interval 322840.85 to 530572.641
|
569464.514 Titer
Interval 422292.607 to 767926.854
|
86417.162 Titer
Interval 51215.401 to 145814.068
|
75962.631 Titer
Interval 52415.295 to 110088.503
|
252871.567 Titer
Interval 96427.352 to 663131.657
|
75683.290 Titer
Interval 53033.587 to 108006.278
|
59813.608 Titer
Interval 32284.811 to 110815.815
|
195254.027 Titer
Interval 117658.578 to 324023.422
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 209
|
61659.500 Titer
Interval 34984.758 to 108672.866
|
123518.877 Titer
Interval 75876.495 to 201075.616
|
84023.351 Titer
Interval 60469.283 to 116752.229
|
69791.093 Titer
Interval 52610.682 to 92581.896
|
28268.320 Titer
Interval 14750.596 to 54173.939
|
74683.080 Titer
Interval 55359.1 to 100752.405
|
86297.855 Titer
Interval 34927.116 to 213224.58
|
41495.404 Titer
Interval 31129.203 to 55313.61
|
62791.376 Titer
Interval 32873.371 to 119937.712
|
112287.997 Titer
Interval 57588.133 to 218944.311
|
|
Geometric Mean Titer (GMT) of Antibody Against S-2P
Day 394
|
54083.734 Titer
Interval 29885.281 to 97875.95
|
115722.196 Titer
Interval 48958.299 to 273531.291
|
151979.746 Titer
Interval 65657.023 to 351795.467
|
116091.387 Titer
Interval 57500.772 to 234383.115
|
44800.794 Titer
Interval 6793.925 to 295427.35
|
120837.018 Titer
Interval 43121.651 to 338613.777
|
169160.905 Titer
Interval 75032.538 to 381373.369
|
91474.491 Titer
Interval 17505.769 to 477990.007
|
267485.349 Titer
Interval 100394.424 to 712673.167
|
47973.345 Titer
Interval 24336.78 to 94566.406
|
SECONDARY outcome
Timeframe: Day 1 to 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.
Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against RBD
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Seroconverted Against RBD
Day 15
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
60 percentage of participants
Interval 26.2 to 87.8
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
60 percentage of participants
Interval 26.2 to 87.8
|
90 percentage of participants
Interval 55.5 to 99.7
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 29
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
80 percentage of participants
Interval 44.4 to 97.5
|
100 percentage of participants
Interval 69.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 36
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 43
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 57
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 119
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 209
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 66.4 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Who Seroconverted Against RBD
Day 394
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 73.5 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 59.0 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 to 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.
Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against S-2P (Wa-1)
Outcome measures
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 Participants
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 Participants
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 Participants
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 Participants
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 15
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 119
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 29
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
90 percentage of participants
Interval 55.5 to 99.7
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 36
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 43
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 57
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 209
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 66.4 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Who Seroconverted Against S-2P
Day 394
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 73.5 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 59.0 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
Adverse Events
25 mcg of mRNA-1273: 18-55 Years
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
50 mcg of mRNA-1273:18-55 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
100 mcg of mRNA-1273: 18-55 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
250 mcg of mRNA-1273: 18-55 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
25 mcg of mRNA-1273: 56-70 Years
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
50 mcg of mRNA-1273: 56-70 Years
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
100 mcg of mRNA-1273: 56-70 Years
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
25 mcg of mRNA-1273: 71+ Years
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
50 mcg of mRNA-1273: 71+ Years
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
100 mcg of mRNA-1273: 71+ Years
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
Other adverse events
| Measure |
25 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
50 mcg of mRNA-1273:18-55 Years
n=15 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
100 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
250 mcg of mRNA-1273: 18-55 Years
n=15 participants at risk
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
|
25 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
50 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
100 mcg of mRNA-1273: 56-70 Years
n=10 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
|
25 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
50 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
100 mcg of mRNA-1273: 71+ Years
n=10 participants at risk
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Eye disorders
Retinal tear
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Eye disorders
Visual field defect
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Parotid duct obstruction
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Oral lichenoid reaction
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Fatigue
|
46.7%
7/15 • Number of events 9 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
10/15 • Number of events 18 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
12/15 • Number of events 16 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
10/15 • Number of events 15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 6 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
5/10 • Number of events 6 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
70.0%
7/10 • Number of events 10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
5/10 • Number of events 9 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
70.0%
7/10 • Number of events 10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Feeling jittery
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site irritation
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site muscle weakness
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Malaise
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site erythema
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
26.7%
4/15 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
26.7%
4/15 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site induration
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
3/15 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
26.7%
4/15 • Number of events 7 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
5/10 • Number of events 6 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vessel puncture site bruise
|
13.3%
2/15 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Energy increased
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Pustule
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Onychomycosis
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Paronychia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Wound
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Exposure via inhalation
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Heart rate increased
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Bone density decreased
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
53.3%
8/15 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.7%
4/15 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
6/15 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
53.3%
8/15 • Number of events 9 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
86.7%
13/15 • Number of events 17 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
60.0%
6/10 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
70.0%
7/10 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
60.0%
6/10 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 6 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
10/15 • Number of events 13 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
10/15 • Number of events 13 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
15/15 • Number of events 21 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.0%
3/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
70.0%
7/10 • Number of events 7 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Bipolar II disorder
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic spasm
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Vascular disorders
Systolic hypertension
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
13.3%
2/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
46.7%
7/15 • Number of events 7 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
26.7%
4/15 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
4/10 • Number of events 4 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
3/15 • Number of events 3 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
12/15 • Number of events 13 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
12/15 • Number of events 14 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
2/10 • Number of events 2 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
5/10 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
5/10 • Number of events 5 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
6.7%
1/15 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
6/15 • Number of events 6 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
53.3%
8/15 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/10 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
10.0%
1/10 • Number of events 1 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site pain
|
73.3%
11/15 • Number of events 20 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
93.3%
14/15 • Number of events 26 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
15/15 • Number of events 29 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
15/15 • Number of events 29 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
60.0%
6/10 • Number of events 8 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
90.0%
9/10 • Number of events 14 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
90.0%
9/10 • Number of events 16 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
8/10 • Number of events 12 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
70.0%
7/10 • Number of events 11 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
10/10 • Number of events 18 • Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60