Influenza
Conditions
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.
Interventions
BIOLOGICALVero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
BIOLOGICALLicensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seroconversion Antibody Titer | 21 days | 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. |
| Percentage of Subjects With Seroprotective Antibody Titer | 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination | 21 days | — |
| Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | 21 days | — |
| Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 180 days | — |
| Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination | 21 days | — |
| Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | 21 days | Change in geometric mean of titers at day 21 compared to baseline |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| VCIV (50-64 Years) Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age | 1,762 |
| VCIV (65+ Years) Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older | 1,080 |
| EIV (50-64 Years) Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age | 229 |
| EIV (65+ Years) Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older | 137 |
| Total | 3,208 |
Baseline characteristics
| Characteristic | VCIV (50-64 Years) | Total | EIV (65+ Years) | EIV (50-64 Years) | VCIV (65+ Years) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1217 Participants | 137 Participants | 0 Participants | 1080 Participants |
| Age, Categorical Between 18 and 65 years | 1762 Participants | 1991 Participants | 0 Participants | 229 Participants | 0 Participants |
| Age, Continuous | 56.3 years STANDARD_DEVIATION 4.29 | 63.8 years STANDARD_DEVIATION 5.08 | 71 years STANDARD_DEVIATION 5.87 | 56.7 years STANDARD_DEVIATION 4.56 | 71.4 years STANDARD_DEVIATION 5.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 159 Participants | 241 Participants | 9 Participants | 15 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1603 Participants | 2967 Participants | 128 Participants | 214 Participants | 1022 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 168.9 cm STANDARD_DEVIATION 9.93 | 168.36 cm STANDARD_DEVIATION 9.9 | 167.9 cm STANDARD_DEVIATION 10.35 | 168.8 cm STANDARD_DEVIATION 9.7 | 167.8 cm STANDARD_DEVIATION 9.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants | 14 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 31 Participants | 0 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 217 Participants | 310 Participants | 6 Participants | 25 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 8 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1497 Participants | 2834 Participants | 131 Participants | 198 Participants | 1008 Participants |
| Region of Enrollment United States | 1762 participants | 3208 participants | 137 participants | 229 participants | 1080 participants |
| Sex: Female, Male Female | 1068 Participants | 1701 Participants | 64 Participants | 91 Participants | 478 Participants |
| Sex: Female, Male Male | 694 Participants | 1507 Participants | 73 Participants | 138 Participants | 602 Participants |
| Weight (kg) | 85.6 kg STANDARD_DEVIATION 21.06 | 83.83 kg STANDARD_DEVIATION 19.31 | 81.2 kg STANDARD_DEVIATION 15.93 | 86.4 kg STANDARD_DEVIATION 21.38 | 82.1 kg STANDARD_DEVIATION 18.53 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 828 | 3 / 474 | 0 / 227 | 0 / 136 | 1 / 923 | 1 / 602 |
| other Total, other adverse events | 777 / 828 | 297 / 474 | 183 / 227 | 95 / 136 | 492 / 923 | 346 / 602 |
| serious Total, serious adverse events | 32 / 828 | 28 / 474 | 4 / 227 | 10 / 136 | 25 / 923 | 32 / 602 |
Outcome results
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.
Time frame: 21 days
Population: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | B | 46.6 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H3N2 | 68.3 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H1N1 | 47.1 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H3N2 | 58.1 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H1N1 | 36.8 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | B | 36.3 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H1N1 | 63.8 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H3N2 | 85.1 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroconversion Antibody Titer | B | 62.9 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H3N2 | 67.9 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | B | 51.5 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroconversion Antibody Titer | A/H1N1 | 37.3 percentage of participants |
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.
Time frame: 21 days
Population: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 21 | 74.3 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 21 | 86.2 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 1 | 43.1 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 1 | 29.6 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 1 | 45.7 percentage of participants |
| VCIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 21 | 90 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 21 | 82.6 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 1 | 35.3 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 21 | 72.6 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 1 | 58 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 21 | 91.3 percentage of participants |
| VCIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 1 | 49.1 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 1 | 44.8 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 21 | 95.9 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 1 | 26.7 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 21 | 93.7 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 1 | 42.1 percentage of participants |
| EIV (50-64 Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 21 | 86.9 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 1 | 52.2 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 1 | 51.5 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 1 | 36.6 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | B Day 21 | 94.8 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H1N1 Day 21 | 75.4 percentage of participants |
| EIV (65+ Years) | Percentage of Subjects With Seroprotective Antibody Titer | A/H3N2 Day 21 | 95.5 percentage of participants |
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
Time frame: 21 days
Population: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H1N1 | 4.61 HIA Titers |
| VCIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | B | 4.28 HIA Titers |
| VCIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H3N2 | 8.96 HIA Titers |
| VCIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H1N1 | 3.32 HIA Titers |
| VCIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | B | 3.04 HIA Titers |
| VCIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H3N2 | 5.65 HIA Titers |
| EIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H3N2 | 15.04 HIA Titers |
| EIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H1N1 | 6.87 HIA Titers |
| EIV (50-64 Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | B | 7.37 HIA Titers |
| EIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H1N1 | 3.29 HIA Titers |
| EIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | B | 4.57 HIA Titers |
| EIV (65+ Years) | Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline | A/H3N2 | 8.07 HIA Titers |
Secondary
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
Time frame: 21 days
Population: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 1 | 24.7 HIA Titers |
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 21 | 221.2 HIA Titers |
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 21 | 79.5 HIA Titers |
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 21 | 122.5 HIA Titers |
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 1 | 28.6 HIA Titers |
| VCIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 1 | 17.2 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 21 | 95.5 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 1 | 41.6 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 1 | 20.3 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 21 | 67.2 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 21 | 234.9 HIA Titers |
| VCIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 1 | 31.4 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 21 | 181.6 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 1 | 23.8 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 1 | 24.6 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 21 | 358.6 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 1 | 15.5 HIA Titers |
| EIV (50-64 Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 21 | 106.5 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 21 | 151.4 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 1 | 39.7 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H3N2 Day 21 | 320 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 21 | 68.7 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | A/H1N1 Day 1 | 20.9 HIA Titers |
| EIV (65+ Years) | Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination | B Day 1 | 33.1 HIA Titers |
Secondary
Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination
Time frame: 21 days
Population: Safety dataset contains all vaccinated subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VCIV (50-64 Years) | Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination | 625 Participants |
| VCIV (65+ Years) | Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination | 222 Participants |
| EIV (50-64 Years) | Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination | 73 Participants |
| EIV (65+ Years) | Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination | 34 Participants |
Secondary
Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VCIV (50-64 Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 620 Participants |
| VCIV (65+ Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 325 Participants |
| EIV (50-64 Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 169 Participants |
| EIV (65+ Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 88 Participants |
| VCIV + EIV (50-64 Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 685 Participants |
| VCIV + EIV (65+ Years) | Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period | 428 Participants |
Secondary
Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination
Time frame: 21 days
Population: Safety dataset contains all vaccinated subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VCIV (50-64 Years) | Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination | 985 Participants |
| VCIV (65+ Years) | Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination | 465 Participants |
| EIV (50-64 Years) | Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination | 119 Participants |
| EIV (65+ Years) | Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination | 53 Participants |