Trial Outcomes & Findings for Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017) (NCT NCT01827462)

NCT ID: NCT01827462

Last Updated: 2017-07-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 136 participants
• Primary outcome timeframe: Day 0 annually while on study
• Results posted on: 2017-07-11

Participant Flow

Participant milestones

Measure	18-30 Years Old at Enrollment Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	60-79 Years Old at Enrollment Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	80-100 Years Old at Enrollment Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly
Overall Study STARTED	59	37	40
Overall Study COMPLETED	18	19	12
Overall Study NOT COMPLETED	41	18	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)

Baseline characteristics by cohort

Measure	18-30 Years Old at Enrollment n=59 Participants Participants receive the licensed annual, Fluzone® This vaccine is given intramuscularly	60-79 Years Old at Enrollment n=37 Participants Participants receive the licensed annual vaccine, Fluzone® This vaccine is given intramuscularly	80-100 Years Old at Enrollment n=40 Participants Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone® This vaccine is given intramuscularly	Total n=136 Participants Total of all reporting groups
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
Age, Continuous	29.6 years STANDARD_DEVIATION 2.9 • n=5 Participants	73.3 years STANDARD_DEVIATION 5.0 • n=7 Participants	89.5 years STANDARD_DEVIATION 4.3 • n=5 Participants	70.9 years STANDARD_DEVIATION 23.1 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants	78 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	37 Participants n=7 Participants	40 Participants n=5 Participants	130 Participants n=4 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
Race (NIH/OMB) Asian	12 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 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	0 Participants n=4 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
Race (NIH/OMB) White	37 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	111 Participants n=4 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	59 participants n=5 Participants	37 participants n=7 Participants	40 participants n=5 Participants	136 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0 annually while on study

Outcome measures

Measure	18-30 Years Old at Enrollment n=59 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	60-79 Years Old at Enrollment n=37 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	80-100 Years Old at Enrollment n=40 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly
Number of Participants Who Received the Influenza Vaccine	59 Participants	37 Participants	40 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 28 following each annual vaccination while on study

Related adverse events were recorded annually during this 10 year longitudinal study.

Outcome measures

Measure	18-30 Years Old at Enrollment n=59 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	60-79 Years Old at Enrollment n=37 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly	80-100 Years Old at Enrollment n=40 Participants Participants receive the licensed annual trivalent vaccine, Fluzone® This vaccine is given intramuscularly
Number of Participants With Related Adverse Events Rash at injection site	0 Participants	0 Participants	1 Participants
Number of Participants With Related Adverse Events Pain at injection site	1 Participants	0 Participants	0 Participants
Number of Participants With Related Adverse Events Erythema at injection site	0 Participants	0 Participants	1 Participants
Number of Participants With Related Adverse Events Flushing	0 Participants	1 Participants	0 Participants
Number of Participants With Related Adverse Events High White Blood Cell Count	0 Participants	1 Participants	0 Participants
Number of Participants With Related Adverse Events Lymphopenia	0 Participants	0 Participants	1 Participants
Number of Participants With Related Adverse Events Thrombocytopenia	1 Participants	0 Participants	0 Participants
Number of Participants With Related Adverse Events No Related Adverse Events	57 Participants	35 Participants	37 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to 7

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0-Day28

Outcome measures

Outcome data not reported

Adverse Events

18-30 Years Old at Enrollment

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

60-79 Years Old at Enrollment

Serious events: 20 serious events

Other events: 29 other events

Deaths: 2 deaths

80-100 Years Old at Enrollment

Serious events: 34 serious events

Other events: 21 other events

Deaths: 16 deaths

Serious adverse events

Measure	18-30 Years Old at Enrollment n=59 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season. This vaccine is given intramuscularly	60-79 Years Old at Enrollment n=37 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly	80-100 Years Old at Enrollment n=40 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly
Cardiac disorders Myocardial Infarction	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Congestive Heart Failure	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	15.0% 6/40 • Number of events 6 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Atrial Fibrillation	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Hypetension	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Hypotension	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Chest Pain	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Calcium Channel Blocker Overdose	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Bradycardia	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Pericarditis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Syncopal Episode	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Cardiac disorders Death	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Ulcer	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Diverticulitis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Abdominal Pain	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Nausea/Vomiting	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
General disorders Diminished Cognition	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
General disorders Weakness Worsening	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
General disorders Death	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Pneumonia	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Prosthetic Hip Infection	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Cellulitis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Systemic Inflammatory Response Syndrone	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Scabies	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Death	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Metabolism and nutrition disorders Alcohol Detoxification	1.7% 1/59 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Musculoskeletal and connective tissue disorders Fractures/Accidents	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 6 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Musculoskeletal and connective tissue disorders Contusions/observation/hit by car	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Musculoskeletal and connective tissue disorders Degenerative Joint Disease-pain	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cancer	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Nervous system disorders Parkinson's	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Nervous system disorders Syncopal Episode	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Psychiatric disorders Depression	1.7% 1/59 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Renal and urinary disorders UTI	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Renal and urinary disorders Urosepsis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	12.5% 5/40 • Number of events 7 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Pleural Effusions/bilateral	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Appendectomy	1.7% 1/59 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Hip Arthroplasty	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 4 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	17.5% 7/40 • Number of events 9 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Bladder resection/transurethral	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Diaphragmatic Hernia Repair	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Microdiskectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Pancreatoduodenectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Perforated Pylric Ulcer repair	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Inguinal Hernia Repair	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Pacemaker Placement	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Node Ablation	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Hemicolectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Aortic Valve Replacement	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Arthrectomy-Femoral Artery	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Decompression of Lumbar Stenosis	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Femur Fracture Repair	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Cardioversion	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Cholecystectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Colectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Pancreatic Stent Placement	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Biliary Stent Placement	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Inferior Vena Cava Filter	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Venoplasty	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Diverticulectomy	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Surgical and medical procedures Ankle Fracture	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Vascular disorders Amnesia-Tansient	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Vascular disorders Stroke	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Vascular disorders Subarachnoid Hemorrhage	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/37 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Vascular disorders Death	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.0% 2/40 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.

Other adverse events

Measure	18-30 Years Old at Enrollment n=59 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season. This vaccine is given intramuscularly	60-79 Years Old at Enrollment n=37 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly	80-100 Years Old at Enrollment n=40 participants at risk Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season. This vaccine is given intramuscularly
Infections and infestations Upper respiratory infection	23.7% 14/59 • Number of events 15 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	40.5% 15/37 • Number of events 17 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	12.5% 5/40 • Number of events 5 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Influenza Type Illness	11.9% 7/59 • Number of events 7 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	0.00% 0/40 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Rhinitis	11.9% 7/59 • Number of events 7 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Musculoskeletal and connective tissue disorders Lower Back Pain	1.7% 1/59 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	8.1% 3/37 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.7% 1/37 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	10.0% 4/40 • Number of events 4 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Gastrointestinal disorders Diarrhea	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	8.1% 3/37 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	2.5% 1/40 • Number of events 1 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Blood and lymphatic system disorders Anemia	0.00% 0/59 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	10.0% 4/40 • Number of events 4 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.
Infections and infestations Urinary Tract Infection	3.4% 2/59 • Number of events 2 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	5.4% 2/37 • Number of events 3 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.	7.5% 3/40 • Number of events 4 • Unsolicited adverse events were reported during the 28 day period following each annual immunization. Serious adverse events were reported on an annual basis for this 10 year longitudinal study. Because serious adverse events were reported on an annual basis for this 10 year longitudinal study, individual participants often had multiple different adverse events over the course of their participation.

Additional Information

Dr Cornelia Dekker

Stanford University School of Medicine, Dept. of Pediatrics

Phone: 650-724-4437

Email: cdekker@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place