Influenza
Conditions
Keywords
Influenza, Fluzone®
Brief summary
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Detailed description
Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.
Interventions
BIOLOGICALInfluenza virus vaccine
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
: * Age of 18 years or greater. * Ambulatory. * In reasonably good health as assessed by the investigator. * Available for duration of the study (21 days + 2d). * Willing and able to meet protocol requirements. * 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) or 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. * Immunosuppressive therapy including long-term (\> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing. * Receipt of blood or blood products within the 3 months preceding enrollment in the study. * Diabetes * Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.). * 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 Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Days 0 to 3 Post-vaccination | Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia |
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | Day 0 and Day 21 Post-vaccination | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. |
| Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | Day 21 Post-vaccination | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. |
| Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | Day 21 Post-vaccination | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated from 25 July 2003 to 26 August 2003 at 1 US site.
Pre-assignment details
A total of 121 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone® Vaccine Group 1 Participants were 18 to 59 years old at enrollment in the study | 61 |
| Fluzone® Vaccine Group 2 Participants were 60 years or older at enrollment in the study | 60 |
| Total | 121 |
Baseline characteristics
| Characteristic | Fluzone® Vaccine Group 1 | Fluzone® Vaccine Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 55 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 5 Participants | 65 Participants |
| Age, Continuous Age Continuous | 40.7 Years STANDARD_DEVIATION 10.43 | 73.7 Years STANDARD_DEVIATION 6.16 | 57.1 Years STANDARD_DEVIATION 18.65 |
| Region of Enrollment United States | 61 participants | 60 participants | 121 participants |
| Sex: Female, Male Female | 48 Participants | 39 Participants | 87 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 61 | 2 / 60 |
| serious Total, serious adverse events | 0 / 61 | 0 / 60 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 21 Post-vaccination
Population: The Geometric mean titers were analyzed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/Panama/2007/99 Pre-Dose | 29.6 Titers |
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/Panama/2007/99 Post-Dose | 67.1 Titers |
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/New Caledonia/20/99 Pre-Dose | 18.3 Titers |
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/New Caledonia/20/99 Post-Dose | 46.3 Titers |
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | B/Hong Kong/1434/2002 Pre-Dose | 10.7 Titers |
| Fluzone® Vaccine Group 1 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | B/Hong Kong/1434/2002 Post-Dose | 27.8 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | B/Hong Kong/1434/2002 Pre-Dose | 8.2 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/Panama/2007/99 Pre-Dose | 20.4 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/New Caledonia/20/99 Post-Dose | 15.1 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/Panama/2007/99 Post-Dose | 37.5 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | B/Hong Kong/1434/2002 Post-Dose | 15.9 Titers |
| Fluzone® Vaccine Group 2 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | A/New Caledonia/20/99 Pre-Dose | 9.5 Titers |
Primary
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 21 Post-vaccination
Population: The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group 1 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | A/Panama/2007/99 | 28 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | A/New Caledonia/20/99 | 30 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | B/Hong Kong/1434/2002 | 38 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | A/Panama/2007/99 | 18 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | A/New Caledonia/20/99 | 8 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | B/Hong Kong/1434/2002 | 22 Percentage of Participants |
Primary
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay
Time frame: Day 21 Post-vaccination
Population: The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group 1 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | A/Panama/2007/99 | 74 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | A/New Caledonia/20/99 | 62 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | B/Hong Kong/1434/2002 | 41 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | A/Panama/2007/99 | 60 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | A/New Caledonia/20/99 | 25 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | B/Hong Kong/1434/2002 | 25 Percentage of Participants |
Primary
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Time frame: Days 0 to 3 Post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Induration (> 5 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Bruising | 10 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Pain (Decreased ability to move arm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Fever | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Arthralgia | 5 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Erythema | 15 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Erythema (> 5 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Induration | 20 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Bruising (> 5 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Pain | 75 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Fever (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Chills | 5 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Chills (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Rash | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Rash (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Headache | 23 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Headache (Incapacitating) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Cough | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Cough (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Runny Nose | 5 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Runny Nose (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Nausea | 7 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Nausea (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Vomiting | 2 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Vomiting (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Diarrhea | 3 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Diarrhea (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Malaise | 10 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Malaise (Incapacitating) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Myalgia | 13 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Myalgia (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 1 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Arthralgia (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Arthralgia (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Induration (> 5 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Headache (Incapacitating) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Vomiting (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Pain (Decreased ability to move arm) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Cough | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Fever | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Malaise (Incapacitating) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Arthralgia | 3 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Cough (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Erythema | 7 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Diarrhea | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Erythema (> 5 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Runny Nose | 3 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Induration | 12 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Bruising | 3 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Myalgia (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Bruising (> 5 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Runny Nose (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Pain | 12 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Diarrhea (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Fever (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Nausea | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Chills | 2 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Myalgia | 5 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Chills (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Nausea (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Rash | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Malaise | 3 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Grade 3 Rash (Incapacitating) | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Vomiting | 0 Percentage of Participants |
| Fluzone® Vaccine Group 2 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Any Headache | 7 Percentage of Participants |