Influenza
Conditions
Keywords
Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Influenza vaccines
Brief summary
The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2
Detailed description
Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.
Interventions
0.5 mL Intramuscular
BIOLOGICALTrivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 50 to 64 years (inclusive) on the day of vaccination * Informed consent form has been signed and dated * Medically stable * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
Exclusion criteria
* Known pregnancy, or a positive urine pregnancy test * Currently breastfeeding a child * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw) * Receipt of seasonal or pandemic influenza vaccine in the past 6 months * Receipt of blood or blood-derived products in the past 3 months * Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy * Neoplastic disease or any hematologic malignancy * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * Personal history of Guillain-Barré Syndrome * Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | Day 0 and Day 28 post-vaccination | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. |
| Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Day 0 and Day 28 Post-vaccination | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. |
| Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Day 0 and Day 28 post-vaccination | Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. |
| Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Day 0 and Day 28 post vaccination | Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Day 0 through Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.
Pre-assignment details
A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone® High-Dose Vaccine Group Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 | 148 |
| Fluzone® Vaccine Group Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0 | 152 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Fluzone® Vaccine Group | Fluzone® High-Dose Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants | 148 Participants | 300 Participants |
| Age, Continuous | 57.7 Years STANDARD_DEVIATION 4.14 | 57.6 Years STANDARD_DEVIATION 4.38 | 57.7 Years STANDARD_DEVIATION 4.25 |
| Region of Enrollment United States | 152 Participants | 148 Participants | 300 Participants |
| Sex: Female, Male Female | 96 Participants | 98 Participants | 194 Participants |
| Sex: Female, Male Male | 56 Participants | 50 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 130 / 148 | 110 / 152 |
| serious Total, serious adverse events | 0 / 148 | 0 / 152 |
Outcome results
Primary
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time frame: Day 0 and Day 28 Post-vaccination
Population: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® High-Dose Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California | 21.8 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria | 22.0 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane | 6.27 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California | 21.2 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria | 12.0 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane | 3.91 1/dilution (1/dil) |
Primary
Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time frame: Day 0 and Day 28 post-vaccination
Population: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H1N1: California - Pre-vaccination (N=147, 152) | 40.5 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H3N2: Victoria - Pre-vaccination (N=147, 152) | 36.4 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | B: Brisbane - Pre-vaccination (N=147, 152) | 27.4 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H1N1: California - Post-vaccination (N=145, 151) | 1067 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H3N2: Victoria - Post-vaccination (N = 145, 151) | 936 1/dilution (1/dil) |
| Fluzone® High-Dose Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | B: Brisbane - Post-vaccination (N=145, 151) | 203 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H3N2: Victoria - Post-vaccination (N = 145, 151) | 567 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H1N1: California - Pre-vaccination (N=147, 152) | 28.8 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H1N1: California - Post-vaccination (N=145, 151) | 745 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | A/H3N2: Victoria - Pre-vaccination (N=147, 152) | 41.4 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | B: Brisbane - Post-vaccination (N=145, 151) | 127 1/dilution (1/dil) |
| Fluzone® Vaccine Group | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | B: Brisbane - Pre-vaccination (N=147, 152) | 28.9 1/dilution (1/dil) |
Primary
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time frame: Day 0 and Day 28 post-vaccination
Population: Seroconversion to the vaccine antigens was assessed in the full analysis set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California | 78 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria | 89 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane | 64 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California | 78 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria | 76 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane | 41 Percentage of Participants |
Primary
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time frame: Day 0 and Day 28 post vaccination
Population: Seroprotection was assessed in the full analysis set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California - Pre-vaccination (N=147, 152) | 50 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria - Pre-vaccination (N=147, 152) | 50 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane - Pre-vaccination (N=147, 152) | 46 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California - Post-vaccination (N=145, 151) | 100 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria - Post-vaccination (N=145, 151) | 99 Percentage of Participants |
| Fluzone® High-Dose Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane - Post-vaccination (N=145, 151) | 97 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria - Post-vaccination (N=145, 151) | 98 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California - Pre-vaccination (N=147, 152) | 41 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H1N1: California - Post-vaccination (N=145, 151) | 98 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | A/H3N2: Victoria - Pre-vaccination (N=147, 152) | 51 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane - Post-vaccination (N=145, 151) | 87 Percentage of Participants |
| Fluzone® Vaccine Group | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | B: Brisbane - Pre-vaccination (N=147, 152) | 47 Percentage of Participants |
Secondary
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 through Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Erythema (>100 mm) | 0 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Headache | 46 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Ecchymosis | 1 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Headache (Prevents daily activity) | 5 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Erythema | 11 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Ecchymosis (>100 mm) | 0 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Malaise | 44 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Swelling | 9 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Myalgia | 70 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Induration | 13 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Myalgia (Prevents daily activity) | 10 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grad 3 Injection site Pain-Prevents daily activity | 1 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Shivering | 29 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Induration (>100 mm) | 0 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Shivering (Prevents daily activity) | 7 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Pain | 112 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 0 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Swelling (>100 mm) | 0 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Malaise (Prevents daily activity) | 10 Participants |
| Fluzone® High-Dose Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Fever | 1 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Shivering (Prevents daily activity) | 3 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grad 3 Injection site Pain-Prevents daily activity | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Erythema | 2 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Erythema (>100 mm) | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Swelling | 2 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Swelling (>100 mm) | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Ecchymosis | 1 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Ecchymosis (>100 mm) | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Induration | 3 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Injection Site Induration (>100 mm) | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Fever | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Headache | 40 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Malaise | 38 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Headache (Prevents daily activity) | 3 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Malaise (Prevents daily activity) | 5 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Myalgia | 46 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Myalgia (Prevents daily activity) | 4 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Shivering | 21 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 0 Participants |
| Fluzone® Vaccine Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Any Injection Site Pain | 85 Participants |