Trial Outcomes & Findings for TIV and High Dose TIV in Subjects With Rheumatoid Arthritis (NCT NCT01436370)
NCT ID: NCT01436370
Last Updated: 2014-12-24
Results Overview
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Day 0 prior to and Day 21 following immunization
Results posted on
2014-12-24
Participant Flow
Adults with rheumatoid arthritis (RA) receiving tumor necrosis factor (TNF)-alpha-inhibitor therapy and healthy controls were recruited from existing volunteer populations and the community around the clinical site. Participants were enrolled between 20OCT2011 - 3JAN2012 (2011-2012 vaccine); and 12SEP2012 -14JAN2013 (2012-2013 vaccine).
Participant milestones
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2011-2012 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
10
|
10
|
19
|
19
|
16
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
10
|
10
|
18
|
19
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2011-2012 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
TIV and High Dose TIV in Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2011-2012 Fluzone Standard Dose
n=6 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
50.1 years
STANDARD_DEVIATION 10.8 • n=10 Participants
|
52.8 years
STANDARD_DEVIATION 9.5 • n=115 Participants
|
52.1 years
STANDARD_DEVIATION 9.4 • n=24 Participants
|
49.9 years
STANDARD_DEVIATION 10.0 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
64 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
95 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
99 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
19 participants
n=21 Participants
|
19 participants
n=10 Participants
|
16 participants
n=115 Participants
|
16 participants
n=24 Participants
|
102 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 21 following immunizationPopulation: The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008
|
1 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2)
|
1 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1)
|
4 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 21 following immunizationPopulation: The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010
|
6 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2)
|
9 participants
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1)
|
8 participants
|
12 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: The analysis population includes all participants enrolled and vaccinated in the study.
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 21 and 180Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
B/Brisbane/60/2008 - Day 0
|
22.4 titers
Interval 7.7 to 65.5
|
20.0 titers
Interval 4.3 to 92.0
|
24.6 titers
Interval 11.3 to 53.6
|
23.0 titers
Interval 11.1 to 47.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
B/Brisbane/60/2008 - Day 7
|
31.7 titers
Interval 15.0 to 67.3
|
56.6 titers
Interval 23.2 to 137.9
|
74.6 titers
Interval 32.7 to 170.3
|
80.0 titers
Interval 32.4 to 197.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
B/Brisbane/60/2008 - Day 21
|
40.0 titers
Interval 14.3 to 111.9
|
56.6 titers
Interval 20.8 to 154.2
|
121.3 titers
Interval 50.3 to 292.6
|
130.0 titers
Interval 57.7 to 292.5
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
B/Brisbane/60/2008 - Day 180
|
28.3 titers
Interval 9.4 to 85.2
|
35.6 titers
Interval 12.2 to 104.0
|
56.6 titers
Interval 24.2 to 132.5
|
56.6 titers
Interval 26.8 to 119.6
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/Perth/16/2009 (A/H3N2) - Day 0
|
56.6 titers
Interval 11.7 to 273.8
|
22.4 titers
Interval 6.4 to 78.6
|
37.3 titers
Interval 11.7 to 118.6
|
41.4 titers
Interval 12.4 to 138.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/Perth/16/2009 (A/H3N2) - Day 7
|
89.8 titers
Interval 23.6 to 341.1
|
89.8 titers
Interval 38.4 to 210.2
|
197.0 titers
Interval 75.0 to 517.1
|
139.3 titers
Interval 56.7 to 342.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/Perth/16/2009 (A/H3N2) - Day 21
|
89.8 titers
Interval 23.6 to 341.1
|
71.3 titers
Interval 24.4 to 207.9
|
211.1 titers
Interval 93.3 to 477.6
|
171.5 titers
Interval 83.6 to 351.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/Perth/16/2009 (A/H3N2) - Day 180
|
71.3 titers
Interval 15.1 to 337.3
|
35.6 titers
Interval 15.2 to 83.4
|
65.0 titers
Interval 24.8 to 170.6
|
74.6 titers
Interval 28.9 to 192.6
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/California/7/2009 (A/H1N1) - Day 0
|
10.0 titers
Interval 3.2 to 30.9
|
20.0 titers
Interval 2.8 to 140.8
|
32.5 titers
Interval 13.5 to 78.0
|
42.1 titers
Interval 17.6 to 101.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/California/7/2009 (A/H1N1) - Day 7
|
44.9 titers
Interval 14.0 to 144.0
|
142.5 titers
Interval 37.5 to 541.5
|
160.0 titers
Interval 68.9 to 371.7
|
242.5 titers
Interval 94.7 to 621.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/California/7/2009 (A/H1N1) - Day 21
|
50.4 titers
Interval 23.8 to 106.8
|
285.1 titers
Interval 41.8 to 1944.5
|
288.4 titers
Interval 88.6 to 939.2
|
242.5 titers
Interval 129.5 to 454.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
A/California/7/2009 (A/H1N1) - Day 180
|
15.9 titers
Interval 5.3 to 47.5
|
142.5 titers
Interval 32.3 to 629.2
|
91.9 titers
Interval 30.9 to 273.7
|
85.7 titers
Interval 45.3 to 162.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 0, 7, 21 and 180Population: The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
B/Wisconsin/1/2010 - Day 0
|
10.0 titers
Interval 6.3 to 15.8
|
9.6 titers
Interval 6.4 to 14.5
|
9.8 titers
Interval 6.7 to 14.4
|
7.1 titers
Interval 5.3 to 9.5
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
B/Wisconsin/1/2010 - Day 7
|
21.9 titers
Interval 12.4 to 38.7
|
11.8 titers
Interval 7.9 to 17.6
|
35.1 titers
Interval 21.1 to 58.4
|
19.6 titers
Interval 12.3 to 31.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
B/Wisconsin/1/2010 - Day 21
|
26.8 titers
Interval 16.1 to 44.6
|
14.4 titers
Interval 9.6 to 21.6
|
51.9 titers
Interval 32.3 to 83.4
|
20.0 titers
Interval 13.7 to 29.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
B/Wisconsin/1/2010 - Day 180
|
15.3 titers
Interval 8.6 to 27.1
|
10.8 titers
Interval 7.4 to 15.7
|
16.1 titers
Interval 10.1 to 25.7
|
9.1 titers
Interval 6.2 to 13.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/Victoria/361/2011 (A/H3N2) - Day 0
|
38.6 titers
Interval 19.7 to 75.4
|
38.6 titers
Interval 21.7 to 68.6
|
39.1 titers
Interval 16.6 to 92.5
|
45.6 titers
Interval 21.2 to 97.9
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/Victoria/361/2011 (A/H3N2) - Day 7
|
109.1 titers
Interval 62.7 to 189.8
|
97.8 titers
Interval 52.7 to 181.5
|
167.1 titers
Interval 75.7 to 368.8
|
226.3 titers
Interval 125.7 to 407.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/Victoria/361/2011 (A/H3N2) - Day 21
|
143.4 titers
Interval 81.0 to 253.8
|
113.1 titers
Interval 60.9 to 210.3
|
257.7 titers
Interval 136.9 to 484.9
|
252.2 titers
Interval 135.6 to 469.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/Victoria/361/2011 (A/H3N2) - Day 180
|
78.5 titers
Interval 39.7 to 155.0
|
59.8 titers
Interval 33.2 to 107.5
|
115.6 titers
Interval 58.8 to 227.3
|
100.8 titers
Interval 56.5 to 179.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/California/7/2009 (A/H1N1) - Day 0
|
31.8 titers
Interval 19.1 to 53.1
|
92.6 titers
Interval 50.6 to 169.2
|
35.1 titers
Interval 19.4 to 63.4
|
49.7 titers
Interval 20.6 to 119.9
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/California/7/2009 (A/H1N1) - Day 7
|
90.9 titers
Interval 52.2 to 158.3
|
148.7 titers
Interval 87.3 to 253.4
|
207.5 titers
Interval 81.6 to 527.6
|
203.0 titers
Interval 93.9 to 439.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/California/7/2009 (A/H1N1) - Day 21
|
120.6 titers
Interval 75.7 to 192.0
|
160.0 titers
Interval 88.8 to 288.4
|
442.9 titers
Interval 232.4 to 844.0
|
226.3 titers
Interval 109.8 to 466.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
A/California/7/2009 (A/H1N1) - Day 180
|
49.4 titers
Interval 28.3 to 86.4
|
117.3 titers
Interval 61.2 to 225.1
|
123.4 titers
Interval 55.8 to 272.8
|
96.2 titers
Interval 37.3 to 248.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Population: The analysis population includes all participants enrolled and vaccinated in the study.
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Feverishness
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Malaise
|
1 participants
|
0 participants
|
5 participants
|
1 participants
|
13 participants
|
3 participants
|
13 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Myalgia
|
2 participants
|
0 participants
|
4 participants
|
1 participants
|
14 participants
|
2 participants
|
13 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Headache
|
4 participants
|
1 participants
|
3 participants
|
5 participants
|
8 participants
|
5 participants
|
8 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Nausea
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
6 participants
|
1 participants
|
5 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Chills
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Arthralgia
|
6 participants
|
0 participants
|
7 participants
|
0 participants
|
18 participants
|
1 participants
|
14 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Shivering
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Asthenia
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
12 participants
|
0 participants
|
9 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Population: The analysis population includes all participants enrolled and vaccinated in the study.
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Fever
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Population: The analysis population includes all participants enrolled and vaccinated in the study.
Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale
Pain
|
0 participants
|
3 participants
|
1 participants
|
4 participants
|
4 participants
|
6 participants
|
8 participants
|
5 participants
|
|
Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale
Tenderness
|
5 participants
|
5 participants
|
6 participants
|
9 participants
|
6 participants
|
12 participants
|
12 participants
|
10 participants
|
|
Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale
Redness
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale
Swelling
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
6 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Population: The analysis population includes all participants enrolled and vaccinated in the study.
Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 Participants
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions
Redness
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions
Swelling
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
6 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 0 prior to and Days 7 and 180 following immunizationPopulation: The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.
Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008 - Day 7
|
0 participants
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008 - Day 180
|
0 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2) - Day 7
|
1 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2) - Day 180
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 7
|
3 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 180
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 prior to and Days 7 and 180 following immunizationPopulation: The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.
Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010 - Day 180
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010 - Day 7
|
5 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2) - Day 7
|
6 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2) - Day 180
|
5 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 7
|
6 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 180
|
1 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Days 7, 21 and 180Population: All RA participants are included in the analysis population for this outcome measure.
The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: \>12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire
Day 7
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire
Day 21
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire
Day 180
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 prior to and Days 7, 21 and 180 following immunizationPopulation: The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.
Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=6 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008 - Day 7
|
0 participants
|
2 participants
|
4 participants
|
4 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008 - Day 21
|
1 participants
|
3 participants
|
6 participants
|
5 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Brisbane/60/2008 - Day 180
|
0 participants
|
1 participants
|
3 participants
|
3 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2) - Day 7
|
1 participants
|
2 participants
|
6 participants
|
5 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2) - Day 21
|
1 participants
|
2 participants
|
6 participants
|
6 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Perth/16/2009 (A/H3N2) - Day 180
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 7
|
3 participants
|
4 participants
|
6 participants
|
5 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 21
|
4 participants
|
4 participants
|
7 participants
|
6 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 180
|
0 participants
|
3 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 prior to and Days 7, 21 and 180 following immunizationPopulation: The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.
Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=19 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2011-2012 Fluzone High Dose
n=16 Participants
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=16 Participants
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010 - Day 7
|
5 participants
|
0 participants
|
6 participants
|
5 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010 - Day 21
|
6 participants
|
3 participants
|
9 participants
|
5 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
B/Wisconsin/1/2010 - Day 180
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2) - Day 7
|
6 participants
|
6 participants
|
7 participants
|
9 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2) - Day 21
|
9 participants
|
8 participants
|
10 participants
|
11 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/Victoria/361/2011 (A/H3N2) - Day 180
|
5 participants
|
2 participants
|
7 participants
|
4 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 7
|
6 participants
|
1 participants
|
9 participants
|
7 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 21
|
8 participants
|
3 participants
|
12 participants
|
7 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
A/California/7/2009 (A/H1N1) - Day 180
|
1 participants
|
2 participants
|
7 participants
|
1 participants
|
—
|
—
|
—
|
—
|
Adverse Events
RA Participants, 2011-2012 Fluzone Standard Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy Controls, 2011-2012 Fluzone Standard Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RA Participants, 2011-2012 Fluzone High Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Healthy Controls, 2011-2012 Fluzone High Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
RA Participants, 2012-2013 Fluzone Standard Dose
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Healthy Controls, 2012-2013 Fluzone Standard Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
RA Participants, 2012-2013 Fluzone High Dose
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Healthy Controls, 2012-2013 Fluzone High Dose
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2011-2012 Fluzone Standard Dose
n=6 participants at risk
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 participants at risk
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 participants at risk
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 participants at risk
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Other adverse events
| Measure |
RA Participants, 2011-2012 Fluzone Standard Dose
n=6 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2011-2012 Fluzone Standard Dose
n=6 participants at risk
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
|
RA Participants, 2011-2012 Fluzone High Dose
n=10 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2011-2012 Fluzone High Dose
n=10 participants at risk
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
|
RA Participants, 2012-2013 Fluzone Standard Dose
n=19 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
Healthy Controls, 2012-2013 Fluzone Standard Dose
n=19 participants at risk
Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
|
RA Participants, 2012-2013 Fluzone High Dose
n=16 participants at risk
Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
Healthy Controls, 2012-2013 Fluzone High Dose
n=16 participants at risk
Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
25.0%
4/16 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
20.0%
2/10 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Swelling
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Feeling hot
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
50.0%
5/10 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
68.4%
13/19 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
15.8%
3/19 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
81.2%
13/16 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
6.2%
1/16 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
40.0%
4/10 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
73.7%
14/19 • Number of events 14 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.5%
2/19 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
81.2%
13/16 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
30.0%
3/10 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
50.0%
5/10 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
42.1%
8/19 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
26.3%
5/19 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
50.0%
8/16 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
30.0%
3/10 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.6%
6/19 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.2%
5/16 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.5%
2/19 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
6/6 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
70.0%
7/10 • Number of events 7 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
94.7%
18/19 • Number of events 18 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
87.5%
14/16 • Number of events 14 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
20.0%
2/10 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
63.2%
12/19 • Number of events 12 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/19 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
56.2%
9/16 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/16 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
50.0%
3/6 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
40.0%
4/10 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
21.1%
4/19 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.6%
6/19 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
50.0%
8/16 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.2%
5/16 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Tenderness
|
83.3%
5/6 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
83.3%
5/6 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
60.0%
6/10 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
90.0%
9/10 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.6%
6/19 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
63.2%
12/19 • Number of events 12 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
75.0%
12/16 • Number of events 12 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
62.5%
10/16 • Number of events 10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
5.3%
1/19 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
15.8%
3/19 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.2%
5/16 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
12.5%
2/16 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.0%
1/10 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/10 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
15.8%
3/19 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.6%
6/19 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
31.2%
5/16 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
37.5%
6/16 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited non-serious adverse events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Additional Information
Jack Stapleton, MD
Department of Internal Medicine, University of Iowa
Phone: 319-356-3168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60