Influenza, Myxovirus Infection, Orthomyxoviruses
Conditions
Keywords
Influenza, Orthomyxoviruses, Split-virion inactivated influenza vaccine, cell-based vaccine, Adults
Brief summary
Primary Objective: To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects. Secondary Objective: To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Detailed description
This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.
Interventions
BIOLOGICALInfluenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
BIOLOGICALInfluenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
BIOLOGICALInfluenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
: * Healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion * Informed consent form signed * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination
Exclusion criteria
: * Subject currently breast-feeding. * 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. * Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01). * Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months. * Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids * Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes). * Receipt of blood or blood-derived products in the 3 months preceding vaccination. * Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination. * History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination. * Previous vaccination against influenza (in the 6 months preceding the trial vaccination). * Planned receipt of any other 2007-2008 influenza vaccine. * Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * History of Guillain-Barré syndrome * Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures * Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | Days 0 and 21 post-vaccination | — |
| Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | Day 21 post-vaccination | Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ) |
| Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | Day 21 post-vaccination | Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Day 0 up to Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.
Pre-assignment details
A total of 729 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Standard Dose Cell-Based Influenza Vaccine Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. | 244 |
| Group 2: High-dose Cell-Based Influenza Vaccine Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. | 241 |
| Group 3: Licensed Fluzone® Influenza Vaccine Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly. | 244 |
| Total | 729 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 9 | 10 |
| Overall Study | Protocol Violation | 5 | 4 | 7 |
| Overall Study | Serious adverse event | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Group 2: High-dose Cell-Based Influenza Vaccine | Group 3: Licensed Fluzone® Influenza Vaccine | Group 1: Standard Dose Cell-Based Influenza Vaccine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 241 Participants | 244 Participants | 244 Participants | 729 Participants |
| Age Continuous | 34.5 Years STANDARD_DEVIATION 9.18 | 34.1 Years STANDARD_DEVIATION 9.42 | 34.4 Years STANDARD_DEVIATION 9.41 | 34.3 Years STANDARD_DEVIATION 9.32 |
| Region of Enrollment United States | 241 participants | 244 participants | 244 participants | 729 participants |
| Sex: Female, Male Female | 162 Participants | 151 Participants | 158 Participants | 471 Participants |
| Sex: Female, Male Male | 79 Participants | 93 Participants | 86 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 158 / 244 | 179 / 241 | 199 / 244 |
| serious Total, serious adverse events | 3 / 244 | 4 / 241 | 6 / 244 |
Outcome results
Primary
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Time frame: Day 21 post-vaccination
Population: Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H3N2: Wisconsin (N = 236, 230, 237) | 50 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H1N1: Solomon Islands (N = 236, 231, 237) | 54 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | B: Malaysia (N = 235, 233, 237) | 38 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H3N2: Wisconsin (N = 236, 230, 237) | 53 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H1N1: Solomon Islands (N = 236, 231, 237) | 63 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | B: Malaysia (N = 235, 233, 237) | 38 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H1N1: Solomon Islands (N = 236, 231, 237) | 74 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | B: Malaysia (N = 235, 233, 237) | 61 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | A/H3N2: Wisconsin (N = 236, 230, 237) | 71 Percentage of Participants |
Primary
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Time frame: Day 21 post-vaccination
Population: Seroprotection was assessed in the full analysis set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237) | 40 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238) | 86 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 0 (N = 236, 232, 237) | 54 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 21 (N = 236, 230, 238) | 94 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 0 (N = 236, 233, 238) | 14 Percentage of Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 21 (N = 235, 233, 237) | 60 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 21 (N = 235, 233, 237) | 64 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237) | 39 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 21 (N = 236, 230, 238) | 98 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 0 (N = 236, 233, 238) | 20 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238) | 90 Percentage of Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 0 (N = 236, 232, 237) | 62 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238) | 98 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 0 (N = 236, 232, 237) | 55 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 21 (N = 235, 233, 237) | 87 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H3N2: Wisconsin Day 21 (N = 236, 230, 238) | 99 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237) | 41 Percentage of Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | B: Malaysia Day 0 (N = 236, 233, 238) | 20 Percentage of Participants |
Primary
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Time frame: Days 0 and 21 post-vaccination
Population: Geometric mean titers were assessed in the full analysis set population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237) | 25.9 Titers |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238) | 184.8 Titers |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237) | 51.2 Titers |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238) | 288.3 Titers |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 0 (N = 236, 233, 238) | 13.4 Titers |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 21 (nN= 235, 233, 237) | 51.1 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 21 (nN= 235, 233, 237) | 53.0 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237) | 26.4 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238) | 351.3 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 0 (N = 236, 233, 238) | 14.3 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238) | 226.6 Titers |
| Group 2: High-dose Cell-Based Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237) | 53.4 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238) | 425.1 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237) | 51.5 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 21 (nN= 235, 233, 237) | 108.6 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238) | 692.4 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237) | 26.6 Titers |
| Group 3: Licensed Fluzone® Influenza Vaccine | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | B: Malaysia, Day 0 (N = 236, 233, 238) | 14.2 Titers |
Secondary
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Headache (Prevents daily activities) | 3 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Ecchymosis | 6 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Pain | 103 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Headache | 75 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Fever (39.0 ºC or 102.2 ºF) | 0 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Induration | 31 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Erythema | 36 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Fever | 13 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Injection Site Reaction | 117 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Systemic Reaction | 114 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Myalgia | 60 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Rigors | 16 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Malaise (Prevents daily activities) | 6 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Swelling | 24 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Pain (incapacitating, prevents activities) | 1 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Malaise | 58 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 1: Standard Dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Rigors (Prevents daily activities) | 2 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Rigors (Prevents daily activities) | 1 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Injection Site Reaction | 156 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Pain | 144 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Rigors | 9 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Pain (incapacitating, prevents activities) | 2 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Erythema | 57 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Swelling | 23 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Ecchymosis | 19 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Induration | 29 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Systemic Reaction | 126 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Fever | 9 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Fever (39.0 ºC or 102.2 ºF) | 0 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Headache | 85 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Headache (Prevents daily activities) | 3 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Malaise | 54 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Malaise (Prevents daily activities) | 4 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Myalgia | 70 Participants |
| Group 2: High-dose Cell-Based Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 3 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Ecchymosis | 14 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Rigors (Prevents daily activities) | 1 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Headache | 89 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Swelling (≥ 5 cm) | 1 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 4 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Headache (Prevents daily activities) | 6 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Swelling | 36 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Pain | 175 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Malaise | 63 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Erythema (≥ 5 cm) | 4 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Rigors | 13 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Malaise (Prevents daily activities) | 5 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Erythema | 55 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Injection Site Reaction | 184 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Solicited Systemic Reaction | 137 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Induration | 38 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Myalgia | 83 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Any Fever | 11 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 1 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Pain (incapacitating, prevents activities) | 1 Participants |
| Group 3: Licensed Fluzone® Influenza Vaccine | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Grade 3 Fever (39.0 ºC or 102.2 ºF) | 2 Participants |