Influenza
Conditions
Keywords
Fluzone®, Influenza, Adults
Brief summary
To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Detailed description
The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period. Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.
Interventions
BIOLOGICALFluzone®: Influenza virus vaccine 2004-2005 formulation
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Participant aged 18 years or older. * Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. * Participant is in reasonably good health as assessed by the investigator. * Participant willing and able to meet protocol requirements. * Participant willing and able to give informed consent.
Exclusion criteria
: * Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. * An acute illness with or without fever (temperature \>100.4°F) in the 72 hours preceding enrollment in the trial. * Clinically significant findings in vital signs (including temperature \>100.4°F) on review of systems. * Self-reported history of severe adverse event to any influenza vaccine. * Vaccination against influenza in the 6 months preceding enrollment in the study. * Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3. * Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study. * Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months. * Receipt of blood or blood products within the 3 months preceding enrollment in the study. * Diabetes mellitus requiring pharmacological control. * Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine. * Person deprived of freedom by an administrative or court order (having legal or medical guardian). * For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | 0 to 3 days post-vaccination | Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia |
| Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | Day 0 and Day 21 Post-Vaccination | GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation. |
| Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | 21 Days post-vaccination | — |
| Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | Day 21 post-vaccination | — |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 06 through 16 August 2004 in 1 US site.
Pre-assignment details
A total of 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years Participants received 1 dose of Fluzone® vaccine on Day 0. | 60 |
| Fluzone® Vaccine Group - Age ≥ 60 Years Participants received 1 dose of Fluzone® vaccine on Day 0. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Fluzone® Vaccine Group - Age ≥ 60 Years | Fluzone® Vaccine Group - Age 18-59 Years | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 0 Participants | 56 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 60 Participants | 64 Participants |
| Age, Continuous | 74 Years STANDARD_DEVIATION 5.9 | 41.3 Years STANDARD_DEVIATION 11.1 | 57.7 Years STANDARD_DEVIATION 18.7 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 38 Participants | 44 Participants | 82 Participants |
| Sex: Female, Male Male | 22 Participants | 16 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 60 | 20 / 60 |
| serious Total, serious adverse events | 0 / 60 | 1 / 60 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Time frame: Day 0 and Day 21 Post-Vaccination
Population: Geometric Mean Titers were assessed in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/NEW CALEDONIA/20/99 (H1N1) Pre-vaccination | 21.3 Titers |
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/New CALEDONIA/20/99 (H1N1) Post-vaccination | 39.3 Titers |
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/WYOMING/03/2003 (H3N2) Pre-vaccination | 34.2 Titers |
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/WYOMING/03/2003 (H3N2) Post-vaccination | 85.7 Titers |
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | B/JIANGSU/10/2003 Pre-vaccination | 8.5 Titers |
| Fluzone® Vaccine Group - Age 18-59 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | B/JIANGSU/10/2003 Pre-vaccination | 23.5 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | B/JIANGSU/10/2003 Pre-vaccination | 10.6 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/NEW CALEDONIA/20/99 (H1N1) Pre-vaccination | 15.6 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/WYOMING/03/2003 (H3N2) Post-vaccination | 64.2 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/New CALEDONIA/20/99 (H1N1) Post-vaccination | 19.8 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | B/JIANGSU/10/2003 Pre-vaccination | 21.5 Titers |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | A/WYOMING/03/2003 (H3N2) Pre-vaccination | 25.6 Titers |
Primary
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Time frame: 21 Days post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/NEW CALEDONIA/20/99 (H1N1) | 60 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/WYOMING/55/2004 (H3N2) | 87 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | B/JIANGSU/10/2003 | 45 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/NEW CALEDONIA/20/99 (H1N1) | 23 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/WYOMING/55/2004 (H3N2) | 78 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | B/JIANGSU/10/2003 | 33 Percentage of Participants |
Primary
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
Time frame: Day 21 post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/NEW CALEDONIA/20/99 (H1N1) | 18 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/WYOMING/55/2004 (H3N2) | 35 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | B/JIANGSU/10/2003 | 47 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/NEW CALEDONIA/20/99 (H1N1) | 5 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | A/WYOMING/55/2004 (H3N2) | 33 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | B/JIANGSU/10/2003 | 23 Percentage of Participants |
Primary
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia
Time frame: 0 to 3 days post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Pain | 60 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Local (Injection Site) Reaction | 60 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Erythema (> 0.5 cm) | 8 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Erythema (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Induration (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Induration (≥ 5.0 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Bruising (> 0.5 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Bruising (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Pain (unable to perform usual activities) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Systemic Reaction | 42 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Fever (≥ 100.4 º F) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Fever (≥ 104.0 º F) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Headache | 23 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Headache (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Chills | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Chills (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Cough | 7 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Cough (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Runny Nose | 8 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Runny Nose (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Rash | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Rash (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Malaise | 7 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Malaise (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Myalgia | 13 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Myalgia (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Arthralgia | 7 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Arthralgia (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Nausea | 8 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Nausea (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Vomiting | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Vomiting (≥ 3 per day) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Diarrhea | 3 Percentage of Participants |
| Fluzone® Vaccine Group - Age 18-59 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Diarrhea (≥ 5 episodes per day) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Myalgia (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Cough (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Local (Injection Site) Reaction | 23 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Diarrhea (≥ 5 episodes per day) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Erythema (> 0.5 cm) | 5 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Runny Nose | 3 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Erythema (≥ 5.0 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Arthralgia | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Induration (> 0.5 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Runny Nose (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Induration (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Vomiting | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Bruising (> 0.5 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Rash | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Bruising (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Pain | 20 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Arthralgia (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Pain (unable to perform usual activities) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Rash (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Systemic Reaction | 23 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Diarrhea | 5 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Fever (≥ 100.4 º F) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Malaise | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Fever (≥ 104.0 º F) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Nausea | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Headache | 8 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Malaise (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Headache (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Vomiting (≥ 3 per day) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Chills | 2 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Myalgia | 8 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Chills (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Nausea (prevents daily activity) | 0 Percentage of Participants |
| Fluzone® Vaccine Group - Age ≥ 60 Years | Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Cough | 3 Percentage of Participants |