Influenza, Myxovirus Infection
Conditions
Keywords
Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
Brief summary
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Interventions
BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
0.1 mL, Intradermal (ID)
BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
0.1 mL, Intradermal (ID)
BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine (Standard dose)
0.5 mL, Intramuscular (IM)
BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine (High-dose)
0.5 mL, Intramuscular (IM)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination. * Informed consent form signed. * Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
Exclusion criteria
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances. * Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test. * Breast feeding woman. * Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years). * Current use of alcohol or recreational drugs that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures. * Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response. * Vaccination against influenza in the past 6 months. * Any vaccination in the 4 weeks preceding the trial vaccination. * Planned receipt of any other vaccine in the four weeks following the trial vaccination. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination. * Planned participation in another clinical trial during the present trial period. Note: Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable. * Known thrombocytopenia or bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * Personal or family history of Guillain-Barré Syndrome. * Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * An acute febrile illness \[oral temperature ≥ 99.5°F (≥ 37.5°C)\] within 24 hours prior to vaccination. If this exists, vaccination will be deferred until the participant becomes afebrile. * Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve. * The use of an antibiotics therapy within 72 hours preceding the trial vaccination. If this exists, vaccination will be deferred until at least 72 hours after the last antibiotics therapy. * Receipt of any allergy shots in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots in the 7-day period after enrollment (vaccination). Subjects should be enrolled in the trial only if their allergy shots are given on a stable schedule outside the 7-day periods pre- and post-vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Day 0 and Day 28 post vaccination | Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay. |
| Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | Day 28 post-vaccination | Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination. |
| Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Day 0 and Day 28 post-vaccination | Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Days 0 through 7 post-vaccination | Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 24 October to 31 October 2007 in 31 medical centers in the US.
Pre-assignment details
A total of 2095 of the 2098 enrolled participants who met the inclusion and exclusion criteria were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Influenza Virus Vaccine Formulation 1 Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System | 635 |
| Influenza Virus Vaccine Formulation 2 Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System | 635 |
| Fluzone® Elderly Group Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM) | 319 |
| Fluzone® High Dose Group Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM) | 320 |
| Fluzone® Adults Group Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM) | 186 |
| Total | 2,095 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Did not receive vaccine | 1 | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Serious Adverse Event | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Influenza Virus Vaccine Formulation 2 | Fluzone® Elderly Group | Fluzone® High Dose Group | Influenza Virus Vaccine Formulation 1 | Fluzone® Adults Group | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 635 Participants | 319 Participants | 320 Participants | 635 Participants | 0 Participants | 1909 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 186 Participants | 186 Participants |
| Age, Continuous | 72.9 Years STANDARD_DEVIATION 5.86 | 73.4 Years STANDARD_DEVIATION 5.91 | 73.0 Years STANDARD_DEVIATION 6 | 73.1 Years STANDARD_DEVIATION 6.03 | 32.2 Years STANDARD_DEVIATION 8.49 | 64.8 Years STANDARD_DEVIATION 6.458 |
| Region of Enrollment United States | 635 Participants | 319 Participants | 320 Participants | 635 Participants | 186 Participants | 2095 Participants |
| Sex: Female, Male Female | 347 Participants | 176 Participants | 183 Participants | 363 Participants | 121 Participants | 1190 Participants |
| Sex: Female, Male Male | 288 Participants | 143 Participants | 137 Participants | 272 Participants | 65 Participants | 905 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 426 / 635 | 434 / 635 | 57 / 319 | 117 / 320 | 106 / 186 |
| serious Total, serious adverse events | 34 / 635 | 38 / 635 | 21 / 319 | 16 / 320 | 7 / 186 |
Outcome results
Primary
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 28 post vaccination
Population: Serum antibody titers GMTs were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 45.3 Titers |
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 348.3 Titers |
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 24.7 Titers |
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 103.8 Titers |
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 18.3 Titers |
| Influenza Virus Vaccine Formulation 1 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 165.4 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 18.6 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 378.4 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 104.7 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 47.5 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 25.1 Titers |
| Influenza Virus Vaccine Formulation 2 | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 174.1 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 17.8 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 107.6 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 95.1 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 276.9 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 24.7 Titers |
| Fluzone® Elderly Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 43.4 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 236.1 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 59.9 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 17.3 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 24.1 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 99.3 Titers |
| Fluzone® High Dose Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 508.0 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 71.2 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 398.3 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 345.8 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 15.5 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 41.4 Titers |
| Fluzone® Adults Group | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 73.0 Titers |
Primary
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Time frame: Day 28 post-vaccination
Population: Serum antibody titers were assessed in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H3N2 (N=605, 608, 304, 309, 179) | 42 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H1N1 (N=604, 607, 304, 309, 179) | 73 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | B (N=607, 608, 304, 309, 179) | 15 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H3N2 (N=605, 608, 304, 309, 179) | 42 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | B (N=607, 608, 304, 309, 179) | 15 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H1N1 (N=604, 607, 304, 309, 179) | 74 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H1N1 (N=604, 607, 304, 309, 179) | 61 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | B (N=607, 608, 304, 309, 179) | 9 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H3N2 (N=605, 608, 304, 309, 179) | 37 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H1N1 (N=604, 607, 304, 309, 179) | 82 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H3N2 (N=605, 608, 304, 309, 179) | 56 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | B (N=607, 608, 304, 309, 179) | 26 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H1N1 (N=604, 607, 304, 309, 179) | 62 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | B (N=607, 608, 304, 309, 179) | 44 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine | A/H3N2 (N=605, 608, 304, 309, 179) | 52 Percentage of Participants |
Primary
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Time frame: Day 0 and Day 28 post-vaccination
Population: Serum antibody titers were assessed in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 27 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 88 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 78 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 65 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 98 Percentage of Participants |
| Influenza Virus Vaccine Formulation 1 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 38 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 98 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 37 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 25 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 90 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 67 Percentage of Participants |
| Influenza Virus Vaccine Formulation 2 | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 79 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 62 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 97 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 80 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 79 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 25 Percentage of Participants |
| Fluzone® Elderly Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 39 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 78 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 23 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 94 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 99 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 37 Percentage of Participants |
| Fluzone® High Dose Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 77 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Pre Dose (N=607, 608, 304, 309, 179) | 25 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Pre Dose (N=606, 608, 304, 309, 179) | 72 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Post Dose (N=605, 607, 304, 309, 179) | 97 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H1N1 Pre Dose (N=604, 607, 304, 309, 179) | 49 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | A/H3N2 Post Dose (N=605, 608, 304, 309, 179) | 99 Percentage of Participants |
| Fluzone® Adults Group | Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | B Post Dose (N=607, 608, 304, 309, 179) | 79 Percentage of Participants |
Secondary
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills
Time frame: Days 0 through 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Swelling (≥ 5 cm) | 50 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Swelling | 286 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pruritus (Prevents daily activities) | 2 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Chills | 21 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Erythema (≥ 5 cm) | 109 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Erythema | 426 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Myalgia | 86 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Induration (≥ 5 cm) | 41 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Ecchymosis | 38 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pruritus | 204 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Headache | 103 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Malaise | 76 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Malaise (Prevents daily activities) | 5 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Fever | 14 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 5 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Induration | 310 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Chills (Prevents daily activities) | 0 Participants |
| Influenza Virus Vaccine Formulation 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pain | 174 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Headache | 89 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Myalgia | 106 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Swelling (≥ 5 cm) | 49 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Swelling | 286 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pruritus | 214 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Chills | 32 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pruritus (Prevents daily activities) | 3 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Chills (Prevents daily activities) | 3 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Erythema (≥ 5 cm) | 108 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Malaise | 98 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Ecchymosis | 41 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pain | 187 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Headache (Prevents daily activities) | 6 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Malaise (Prevents daily activities) | 3 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Induration (≥ 5 cm) | 43 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Erythema | 434 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Fever | 18 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 9 Participants |
| Influenza Virus Vaccine Formulation 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Induration | 311 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Swelling (≥ 5 cm) | 6 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pain | 57 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Erythema | 48 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Swelling | 23 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Induration (≥ 5 cm) | 5 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 2 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Myalgia | 46 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pruritus | 27 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pruritus (Prevents daily activities) | 0 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Erythema (≥ 5 cm) | 5 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Induration | 33 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Ecchymosis | 19 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Fever | 5 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Headache | 41 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Malaise | 42 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Chills | 9 Participants |
| Fluzone® Elderly Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Chills (Prevents daily activities) | 0 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Induration | 45 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Swelling (≥ 5 cm) | 16 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Chills | 28 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 3 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Induration (≥ 5 cm) | 12 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Ecchymosis | 17 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Myalgia | 79 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Malaise (Prevents daily activities) | 3 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Fever | 17 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pain | 117 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 2 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Chills (Prevents daily activities) | 2 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Headache | 59 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Malaise | 50 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pruritus | 17 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pruritus (Prevents daily activities) | 0 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Erythema | 55 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Erythema (≥ 5 cm) | 12 Participants |
| Fluzone® High Dose Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Swelling | 45 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Swelling | 14 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Fever (> 102.2 ºF) | 1 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Chills | 17 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Erythema | 29 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Swelling (≥ 5 cm) | 1 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pruritus (Prevents daily activities) | 0 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Ecchymosis (≥ 5 cm) | 2 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Erythema (≥ 5 cm) | 5 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Myalgia | 68 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Headache | 61 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Ecchymosis | 14 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Induration (≥ 5 cm) | 4 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Malaise (Prevents daily activities) | 6 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Induration | 20 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pain | 106 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Chills (Prevents daily activities) | 2 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Fever | 10 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Malaise | 45 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Fluzone® Adults Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. | Any Injection Site Pruritus | 24 Participants |