Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
Official Title
Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older
Acronym
Not provided
Organization
Alachua Government Services, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Dec 2008Actual
Completion Date
Jul 2009Actual
First Submitted Date
Oct 30, 2008
First Submission Date that Met QC Criteria
Oct 30, 2008
First Posted Date
Oct 31, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2025
Results First Submitted that Met QC Criteria
Dec 11, 2025
Results First Posted Date
Jan 2, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 29, 2009
Certification/Extension First Submitted that Passed QC Review
Oct 29, 2009
Certification/Extension First Posted Date
Oct 30, 2009Estimated
Last Update Submitted Date
Dec 11, 2025
Last Update Posted Date
Jan 2, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alachua Government Services, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition [HI] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,208Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Vero cell-derived, trivalent, seasonal influenza vaccine
Biological: Vero cell derived, trivalent, seasonal influenza vaccine
Vero cell derived, trivalent, seasonal influenza vaccine
Biological
Single intramuscular injection
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With Seroconversion Antibody Titer
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer < 10) at baseline.
21 days
Percentage of Subjects With Seroprotective Antibody Titer
The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.
21 days
Secondary Outcomes
Measure
Description
Time Frame
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
21 days
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
Change in geometric mean of titers at day 21 compared to baseline
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are 50 years of age or older on the day of screening
Have an understanding of the study, agree to its provisions, have the ability to adhere to the provisions of the study and give written informed consent prior to study entry
If female and capable of bearing children,have a negative urine pregnancy test result within 24 hours prior to the vaccination on Study Day 0 and agree to employ adequate birth control measures.
Exclusion Criteria:
History of severe allergic reaction or anaphylaxis to egg protein or any other component of the Vero cell-derived influenza vaccine or the egg-derived influenza vaccine
Oral temperature of >= 99.5°F (37.5°C) on the day of vaccination in this study (Note: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date if certain requirements [in the study protocol] are met)
Rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
Blood transfusion or immunoglobulins received within 90 days of study entry
Live vaccine received within 4 weeks or inactivated vaccine or subunit vaccine received within 2 weeks of study entry
Previous vaccination against influenza for the 2008/2009 northern hemisphere influenza season
Functional or surgical asplenia (e.g. from a history of hemoglobinopathies, leukemias, or lymphomas)
Diagnosed immunodeficiency as a result of a pathological condition
Pharmacologically induced immunodeficiency as a result of prescribed administration of corticosteroids (e.g., any systemic administration of corticosteroids or an inhaled dose equivalent to 800 mg of beclomethasone dipropionate) or chemotherapeutics or as a result of radiation therapy or any other modality capable of altering normal immunologic response
Known or suspected problem with drug or alcohol abuse
Investigational drug received within 6 weeks prior to study entry or concurrent participating in a clinical study that includes the administration of an investigational product
Subjects who are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator.
Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Part A began when the first subject consented to participate in the study and ended when the last subject completed Day 21. Part B began after the first subject completed Day 21 and ended when the last subject completed Day 180. All subjects were randomized to receive a single IM injection of seasonal VCIV or licensed EIV. Only subjects that completed Part A were allowed to enroll in Part B.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
FG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination
21 days
Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination
21 days
Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period
180 days
Tucson
Arizona
85712
United States
Benchmark Research, San Francisco
Sacramento
California
95816
United States
California Research Foundation
San Diego
California
92103-6204
United States
Benchmark Research San Francisco
San Francisco
California
94102
United States
Clinical Research of South Florida
Coral Gables
Florida
33134
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
University Clinical Research, Inc.
Pembroke Pines
Florida
33024
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
Johnson County Clin-Trials
Lenexa
Kansas
66219
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66212
United States
Heartland Research Associates, LLC
Wichita
Kansas
67205
United States
Heartland Research Associates LLC
Wichita
Kansas
67207
United States
Central Kentucky Research Associates, Inc.
Lexington
Kentucky
40509
United States
Center for Pharmaceutical Research
Kansas City
Missouri
64114
United States
Radiant Research, Inc.
St Louis
Missouri
63141
United States
Sundance Clinical Research
St Louis
Missouri
63141
United States
Meridian Clinical Research, LLC
Omaha
Nebraska
68134
United States
Regional Clinical Research, Inc.
Endwell
New York
13760
United States
Rochester Clinical Research Inc.
Rochester
New York
14609
United States
Wake Research Associates, LLC
Raleigh
North Carolina
27612
United States
Omega Medical Research
Warwick
Rhode Island
02886
United States
Palmetto Medical Research
Mt. Pleasant
South Carolina
29464
United States
Clinical Research Associates, Inc. - Nashville
Nashville
Tennessee
37203
United States
Benchmark Research Austin
Austin
Texas
78705
United States
Benchmark Research Ft. Worth
Fort Worth
Texas
76135
United States
Research Across America
Plano
Texas
75093
United States
Benchmark Research San Angelo
San Angelo
Texas
76904
United States
Pi-Coor Clinical Research
Fairfax
Virginia
22030
United States
Clinical Research Associates of Tidewater
Norfolk
Virginia
23507
United States
FG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
FG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
FG004
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
FG005
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
FG000839 subjects
FG001478 subjects
FG002229 subjects
FG003137 subjects
FG004923 subjects
FG005602 subjects
COMPLETED
FG000829 subjects
FG001474 subjects
FG002227 subjects
FG003136 subjects
FG004923 subjects
FG005602 subjects
NOT COMPLETED
FG00010 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Part B
Type
Comment
Milestone Data
STARTED
FG000828 subjects
FG001474 subjects
FG002227 subjects
FG003136 subjects
FG004923 subjects
FG005602 subjects
COMPLETED
FG000804 subjects
FG001458 subjects
FG002227 subjects
FG003134 subjects
FG004
NOT COMPLETED
FG00024 subjects
FG00116 subjects
FG0020 subjects
FG0032 subjects
FG004
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Part A began when the first subject consented to participate in the study and ended when the last subject completed Day 21. All subjects were randomized to receive a single IM injection of seasonal VCIV or licensed EIV. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP, all analysis are performed by treatment group and age stratum.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
BG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
BG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
BG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001762
BG0011080
BG002229
BG003137
BG0043208
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.3± 4.29
BG00171.4± 5.45
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001068
BG001478
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000159
BG00158
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00013
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0001762
BG0011080
BG002
Weight (kg)
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00085.6± 21.06
BG00182.1± 18.53
BG002
Height (cm)
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000168.9± 9.93
BG001167.8± 9.71
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Subjects With Seroconversion Antibody Titer
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer < 10) at baseline.
Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Posted
Number
95% Confidence Interval
percentage of participants
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Units
Counts
Participants
OG0001730
OG0011066
OG002221
OG003
Title
Denominators
Categories
A/H1N1
Title
Measurements
OG00047.1(44.7 to 49.5)
OG00136.8(33.9 to 39.7)
OG00263.8(57.1 to 70.1)
OG003
Primary
Percentage of Subjects With Seroprotective Antibody Titer
The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.
Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Posted
Number
95% Confidence Interval
percentage of participants
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Secondary
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Posted
Geometric Mean
95% Confidence Interval
HIA Titers
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Secondary
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
Change in geometric mean of titers at day 21 compared to baseline
Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Posted
Geometric Mean
95% Confidence Interval
HIA Titers
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Secondary
Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination
Safety dataset contains all vaccinated subjects
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Units
Secondary
Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination
Safety dataset contains all vaccinated subjects
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
Units
Secondary
Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period
Posted
Count of Participants
Participants
180 days
ID
Title
Description
OG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
OG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
OG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
OG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
OG004
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
Time Frame
Not provided
Description
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
1
828
32
828
777
828
EG001
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
3
474
28
474
297
474
EG002
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
0
227
4
227
183
227
EG003
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
0
136
10
136
95
136
EG004
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
1
923
25
923
492
923
EG005
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
1
602
32
602
346
602
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Electromechanical dissociation
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG0030 affected136 at risk
EG0040 affected923 at risk
EG0050 affected602 at risk
Coronary artery disease
Cardiac disorders
Non-systematic Assessment
EG0002 affected828 at risk
EG0012 affected474 at risk
EG0020 affected227 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Thrombosis
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Atrioventricular block
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Abscess rupture
Infections and infestations
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Acute myocardial infarction
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Angina pectoris
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Angina unstable
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Anxiety
Psychiatric disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Aortic valve stenosis
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Appendicitis
Infections and infestations
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Arteriosclerosis
Vascular disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Arteriovenous malformation
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Atrial fibrillation
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0012 affected474 at risk
EG0020 affected227 at risk
EG003
Atrial flutter
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Atrioventricular block complete
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Back injury
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Bladder prolapse
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Blood glucose increased
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0002 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Calculus ureteric
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Cardiac failure congestive
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
EG0002 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Chest pain
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Colon neoplasm
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Convulsion
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Deep vein thrombosis
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Delirium
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Diverticulitis
Gastrointestinal disorders
Non-systematic Assessment
EG0002 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Dizziness
Nervous system disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Facial bones fracture
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Fluid overload
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Fracture malunion
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0012 affected474 at risk
EG0021 affected227 at risk
EG003
Gastroenteritis viral
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Gastrointestinal dysplasia
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Grand mal convulsion
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Hip fracture
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Hypertension
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Hypoaesthesia
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Ileus
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Implantable defibrillator malfunction
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Left atrial dilatation
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Myocardial infarction
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Non-cardiac chest pain
General disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Obesity
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Orthostatic hypotension
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Osteomyelitis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Otitis externa
Eye disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0003 affected828 at risk
EG0010 affected474 at risk
EG0021 affected227 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Post procedural infection
Infections and infestations
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Pulmonary embolism
Vascular disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Rectal polyp
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Retroperitoneal haematoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Sick sinus syndrome
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Sinusitis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Small cell lung cancer stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Staphylococcal infection
Infections and infestations
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Streptococcal infection
Infections and infestations
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Surgical failure
Surgical and medical procedures
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Syncope
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Tachycardia
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Thyroid adenoma
Endocrine disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Transient ischaemic attack
Cardiac disorders
Non-systematic Assessment
EG0001 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Uterovaginal prolapse
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Vena cava thrombosis
Vascular disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Ventricular hypertrophy
Cardiac disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Vertigo
Nervous system disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0011 affected474 at risk
EG0020 affected227 at risk
EG003
Vision blurred
Eye disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected828 at risk
EG0010 affected474 at risk
EG0020 affected227 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG000123 affected828 at risk
EG00146 affected474 at risk
EG00216 affected227 at risk
EG00313 affected136 at risk
EG00460 affected923 at risk
EG00544 affected602 at risk
Diarrhea
Gastrointestinal disorders
Non-systematic Assessment
EG00072 affected828 at risk
EG00139 affected474 at risk
EG00213 affected227 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG000209 affected828 at risk
EG00181 affected474 at risk
EG00227 affected227 at risk
EG003
Chills
General disorders
Non-systematic Assessment
EG000217 affected828 at risk
EG00186 affected474 at risk
EG00221 affected227 at risk
EG003
Fatigue
General disorders
Non-systematic Assessment
EG000448 affected828 at risk
EG001178 affected474 at risk
EG00253 affected227 at risk
EG003
Headache
Nervous system disorders
Non-systematic Assessment
EG000510 affected828 at risk
EG001166 affected474 at risk
EG00270 affected227 at risk
EG003
Hyperhidrosis
Nervous system disorders
Non-systematic Assessment
EG000164 affected828 at risk
EG00143 affected474 at risk
EG00214 affected227 at risk
EG003
Hypertension
Vascular disorders
Non-systematic Assessment
EG00060 affected828 at risk
EG00153 affected474 at risk
EG00212 affected227 at risk
EG003
Injection site pain
General disorders
Non-systematic Assessment
EG000560 affected828 at risk
EG001173 affected474 at risk
EG00269 affected227 at risk
EG003
Malaise
General disorders
Non-systematic Assessment
EG000451 affected828 at risk
EG001176 affected474 at risk
EG00248 affected227 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG000369 affected828 at risk
EG001138 affected474 at risk
EG00248 affected227 at risk
EG003
Nasopharyngitis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00064 affected828 at risk
EG00135 affected474 at risk
EG00217 affected227 at risk
EG003
Nausea
Gastrointestinal disorders
Non-systematic Assessment
EG00071 affected828 at risk
EG00134 affected474 at risk
EG0029 affected227 at risk
EG003
Oropharyngeal pain
Nervous system disorders
Non-systematic Assessment
EG000128 affected828 at risk
EG00148 affected474 at risk
EG00216 affected227 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG00091 affected828 at risk
EG00136 affected474 at risk
EG00216 affected227 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00059 affected828 at risk
EG00135 affected474 at risk
EG00215 affected227 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG00074 affected828 at risk
EG00147 affected474 at risk
EG00231 affected227 at risk
EG003
Blood pressure increased
Vascular disorders
Non-systematic Assessment
EG00073 affected828 at risk
EG00130 affected474 at risk
EG0028 affected227 at risk
EG003
Injection site erythema
General disorders
Non-systematic Assessment
EG00070 affected828 at risk
EG00138 affected474 at risk
EG0026 affected227 at risk
EG003
Injection site swelling
General disorders
Non-systematic Assessment
EG00077 affected828 at risk
EG00140 affected474 at risk
EG0025 affected227 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00080 affected828 at risk
EG00120 affected474 at risk
EG00211 affected227 at risk
EG003
Sinusitis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00047 affected828 at risk
EG00114 affected474 at risk
EG0028 affected227 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG00059 affected828 at risk
EG00131 affected474 at risk
EG0028 affected227 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG00035 affected828 at risk
EG00119 affected474 at risk
EG0028 affected227 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00024 affected828 at risk
EG00116 affected474 at risk
EG00210 affected227 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00051 affected828 at risk
EG00120 affected474 at risk
EG0026 affected227 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Angie Kimbler
Alachua Government Services, Inc.
386-418-8751
angie.kimbler@resilience.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
916 subjects
FG005600 subjects
7 subjects
FG0052 subjects
0
BG0040
Between 18 and 65 years
BG0001762
BG0010
BG002229
BG0030
BG0041991
>=65 years
BG0000
BG0011080
BG0020
BG003137
BG0041217
56.7
± 4.56
BG00371± 5.87
BG00463.8± 5.08
91
BG00364
BG0041701
Male
BG000694
BG001602
BG002138
BG00373
BG0041507
15
BG0039
BG004241
Not Hispanic or Latino
BG0001603
BG0011022
BG002214
BG003128
BG0042967
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
1
BG0030
BG00414
Asian
BG00019
BG0017
BG0025
BG0030
BG00431
Native Hawaiian or Other Pacific Islander
BG0005
BG0011
BG0020
BG0030
BG0046
Black or African American
BG000217
BG00162
BG00225
BG0036
BG004310
White
BG0001497
BG0011008
BG002198
BG003131
BG0042834
More than one race
BG0007
BG0011
BG0020
BG0030
BG0048
Unknown or Not Reported
BG0004
BG0011
BG0020
BG0030
BG0045
229
BG003137
BG0043208
86.4
± 21.38
BG00381.2± 15.93
BG00483.83± 19.31
168.8
± 9.7
BG003167.9± 10.35
BG004168.36± 9.9
134
37.3
(29.1 to 46.1)
A/H3N2
Title
Measurements
OG00068.3(66.1 to 70.5)
OG00158.1(55 to 61.1)
OG00285.1(79.7 to 89.5)
OG00367.9(59.3 to 75.7)
B
Title
Measurements
OG00046.6(44.2 to 49)
OG00136.3(33.4 to 39.3)
OG00262.9(56.2 to 69.3)
OG00351.5(42.7 to 60.2)
Units
Counts
Participants
OG0001730
OG0011066
OG002221
OG003134
Title
Denominators
Categories
A/H1N1 Day 1
Title
Measurements
OG00029.6(27.5 to 31.8)
OG00135.3(32.4 to 38.2)
OG00226.7(21 to 33)
OG00336.6(28.4 to 45.3)
A/H1N1 Day 21
Title
Measurements
OG00074.3(72.2 to 76.4)
OG00172.6(69.8 to 75.3)
OG00286.9(81.7 to 91)
OG003
A/H3N2 Day 1
Title
Measurements
OG00043.1(40.8 to 45.5)
OG00158(54.9 to 61)
OG00244.8(38.1 to 51.6)
OG003
A/H3N2 Day 21
Title
Measurements
OG00090(88.5 to 91.4)
OG00191.3(89.4 to 92.9)
OG00295.9(92.4 to 98.1)
OG003
B Day 1
Title
Measurements
OG00045.7(43.4 to 48.1)
OG00149.1(46 to 52.1)
OG00242.1(35.5 to 48.9)
OG003
B Day 21
Title
Measurements
OG00086.2(84.5 to 87.8)
OG00182.6(80.2 to 84.9)
OG00293.7(89.6 to 96.5)
OG003
Units
Counts
Participants
OG0001730
OG0011066
OG002221
OG003134
Title
Denominators
Categories
A/H1N1 Day 1
Title
Measurements
OG00017.2(16.3 to 18.2)
OG00120.3(18.9 to 21.7)
OG00215.5(13.4 to 18)
OG00320.9(17.3 to 25.3)
A/H1N1 Day 21
Title
Measurements
OG00079.5(74.1 to 85.3)
OG00167.2(62 to 72.9)
OG002106.5(90.8 to 125)
OG003
A/H3N2 Day 1
Title
Measurements
OG00024.7(23 to 26.4)
OG00141.6(38 to 45.5)
OG00223.8(19.9 to 28.6)
OG003
A/H3N2 Day 21
Title
Measurements
OG000221.2(205.5 to 238.1)
OG001234.9(214.7 to 256.9)
OG002358.6(297.2 to 432.8)
OG003
B Day 1
Title
Measurements
OG00028.6(26.8 to 30.6)
OG00131.4(29 to 34)
OG00224.6(20.6 to 29.4)
OG003
B Day 21
Title
Measurements
OG000122.5(115.1 to 130.4)
OG00195.5(88.4 to 103.2)
OG002181.6(155 to 212.7)
OG003
Units
Counts
Participants
OG0001730
OG0011066
OG002221
OG003134
Title
Denominators
Categories
A/H1N1
Title
Measurements
OG0004.61(4.31 to 4.94)
OG0013.32(3.07 to 3.59)
OG0026.87(5.69 to 8.31)
OG0033.29(2.7 to 4)
A/H3N2
Title
Measurements
OG0008.96(8.33 to 9.64)
OG0015.65(5.19 to 6.15)
OG00215.04(12.4 to 18.25)
OG003
B
Title
Measurements
OG0004.28(4.01 to 4.57)
OG0013.04(2.83 to 3.27)
OG0027.37(6.09 to 8.93)
OG003
Counts
Participants
OG0001762
OG0011080
OG002229
OG003137
Title
Denominators
Categories
Title
Measurements
OG000625
OG001222
OG00273
OG00334
Counts
Participants
OG0001762
OG0011080
OG002229
OG003137
Title
Denominators
Categories
Title
Measurements
OG000985
OG001465
OG002119
OG00353
OG005
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.