Influenza, Myxovirus Infection, Orthomyxoviridae Infection
Conditions
Keywords
Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Elderly.
Brief summary
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. 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
0.1 mL, Intradermal
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 65 years on the day of vaccination. * Informed consent form signed. * Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as long as their symptoms/signs are controlled). * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator's Brochure). * 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 follows: * Continuous use with a dosage equivalent to \> 15 mg/day of oral prednisone for 90 days preceding vaccination * Sporadic use with a dose of \> 40 mg/day of oral prednisone for \> 14 days in the 90 days preceding vaccination. Note: Use of topical or inhalant corticosteroids is acceptable. * 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 abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. * Receipt of blood or blood-derived products in the past 3 months. * Vaccination against influenza in the past 6 months. * Any vaccination in the 4 weeks preceding the trial vaccination. * Vaccination planned in the 4 weeks following the trial vaccination. * Participation in another clinical trial in the 4 weeks preceding trial vaccination. * Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable. * Chronic illness at a stage that could interfere with trial conduct or completion. * Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity. * Known thrombocytopenia or bleeding disorder contraindicating IM vaccination. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Acute illness and febrile illness with a temperature ≥ 38.0°C \[or 100.4°F\]) 72 hours before or on the day of inclusion. * Received antibiotics therapy within 72 hours preceding the trial vaccination. * Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination. * Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Pre-vaccination and Day 28 post-vaccination | The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test. |
| Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Day 28 post-vaccination | Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | Pre- and Day 28 post-vaccination | The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test. |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Day 0 up to 7 days post-vaccination | Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics in the US
Pre-assignment details
A total of 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone ID Vaccine Group Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0. | 401 |
| Fluzone IM Vaccine Group Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0. | 406 |
| Total | 807 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive vaccine | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Serious Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Fluzone IM Vaccine Group | Fluzone ID Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 406 Participants | 401 Participants | 807 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 72.3 Years STANDARD_DEVIATION 5.83 | 72.8 Years STANDARD_DEVIATION 6.08 | 72.5 Years STANDARD_DEVIATION 5.955 |
| Region of Enrollment United States | 406 Participants | 401 Participants | 807 Participants |
| Sex: Female, Male Female | 223 Participants | 234 Participants | 457 Participants |
| Sex: Female, Male Male | 183 Participants | 167 Participants | 350 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 282 / 407 | 98 / 409 |
| serious Total, serious adverse events | 33 / 407 | 34 / 409 |
Outcome results
Primary
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Time frame: Day 28 post-vaccination
Population: Immunogenicity determination was in all per protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (N = 400, 406) | 303 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (N = 398, 405) | 391 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Serogroup (N = 400, 406) | 200 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (N = 400, 406) | 292 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (N = 398, 405) | 389 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Serogroup (N = 400, 406) | 213 Participants |
Primary
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time frame: Pre-vaccination and Day 28 post-vaccination
Population: Immunogenicity determination was in all per protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (N = 400, 406) | 119 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (N = 398, 404) | 235 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Serogroup (N = 400, 405) | 105 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (N = 400, 406) | 105 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (N = 398, 404) | 222 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Serogroup (N = 400, 405) | 103 Participants |
Secondary
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time frame: Pre- and Day 28 post-vaccination
Population: Immunogenicity determination was in all per protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (Pre-vaccination) | 27.46 Titers |
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (Post-vaccination) | 71.17 Titers |
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (Pre-vaccination) | 75.95 Titers |
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (Post-vaccination) | 500.65 Titers |
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | B Serogroup (Pre-vaccination) | 13.11 Titers |
| Fluzone Intradermal (ID) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | B Serogroup (Post-vaccination) | 35.06 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | B Serogroup (Pre-vaccination) | 12.95 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (Pre-vaccination) | 24.86 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (Post-vaccination) | 360.42 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H1N1 Serogroup (Post-vaccination) | 59.04 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | B Serogroup (Post-vaccination) | 35.77 Titers |
| Fluzone Intramuscular (IM) Vaccine Group | Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | A/H3N2 Serogroup (Pre-vaccination) | 64.95 Titers |
Secondary
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 up to 7 days post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 105 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 0 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 282 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 39 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 186 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 17 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 178 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 12 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 23 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (Incapacitating) | 1 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 137 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 0 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 10 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (>102.2°F) | 0 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 69 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 2 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 57 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 3 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 68 Participants |
| Fluzone Intradermal (ID) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 4 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 4 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 98 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 23 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 1 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 1 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 49 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 20 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 4 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 4 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 41 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 17 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (>102.2°F) | 1 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 56 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 12 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 63 Participants |
| Fluzone Intramuscular (IM) Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (Incapacitating) | 0 Participants |