Influenza
Conditions
Keywords
Influenza, Fluzone Vaccine, Intradermal Injections, Adults
Brief summary
The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
Detailed description
All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.
Interventions
0.1 mL, Intradermal
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 18 to 64 years on the day of vaccination in study FID33 * Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) for the group to which they were randomized * Informed consent form signed and dated * 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 trial vaccine or to a vaccine containing any of the same substances * For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test * Breast-feeding woman * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period (observational trials will be allowed) * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * Current alcohol abuse 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, that might interfere with the assessment of immune response * Receipt of any vaccination in the 4 weeks preceding the trial vaccination * Planned receipt of any vaccine in the 4 weeks following the trial vaccination * Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity. * Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Neoplastic disease or any hematologic malignancy, (those who have 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 will not be excluded). * Personal or family history of Guillain-Barré Syndrome Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Day 0 through Day 7 post-vaccination | Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Day 0 and Day 28 post-vaccination | Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. |
| Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Day 28 post-vaccination | Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination. |
| Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Day 28 post vaccination | Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled and from 23 September 2009 to 16 October 2009 in 46 medical centers in the US.
Pre-assignment details
A total of 1248 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Fluzone ID After Fluzone ID Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) | 507 |
| Group 2: Fluzone IM After Fluzone ID Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) | 252 |
| Group 3: Fluzone IM After Fluzone IM Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) | 243 |
| Group 4: Fluzone ID After Fluzone IM Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) | 246 |
| Total | 1,248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: Fluzone IM After Fluzone ID | Group 3: Fluzone IM After Fluzone IM | Group 1: Fluzone ID After Fluzone ID | Group 4: Fluzone ID After Fluzone IM | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 242 Participants | 507 Participants | 246 Participants | 1247 Participants |
| Age, Continuous | 44.8 Years STANDARD_DEVIATION 13.26 | 45.8 Years STANDARD_DEVIATION 12.74 | 45.2 Years STANDARD_DEVIATION 13.1 | 43.7 Years STANDARD_DEVIATION 12.78 | 45 Years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 252 Participants | 243 Participants | 507 Participants | 246 Participants | 1248 Participants |
| Sex: Female, Male Female | 161 Participants | 158 Participants | 324 Participants | 155 Participants | 798 Participants |
| Sex: Female, Male Male | 91 Participants | 85 Participants | 183 Participants | 91 Participants | 450 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 412 / 507 | 148 / 252 | 147 / 243 | 183 / 246 |
| serious Total, serious adverse events | 9 / 507 | 2 / 252 | 3 / 243 | 5 / 246 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
Time frame: Day 0 through Day 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) |
|---|---|---|---|
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Ecchymosis | 53 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Fever (> 102.2 ºF) | 1 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Swelling | 343 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Malaise | 98 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Headache | 148 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Headache (Prevents Daily Activities) | 13 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Myalgia (Prevents Daily Activities) | 8 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Myalgia | 131 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Erythema (≥ 5 cm) | 91 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Swelling (≥ 5 cm) | 40 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Fever | 20 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Induration | 310 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Ecchymosis (≥ 5 cm) | 1 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Induration (≥ 5 cm) | 24 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pain | 274 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 16 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Shivering (Prevents Daily Activities) | 8 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pain (Incapacitating) | 5 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Erythema | 412 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pruritus | 257 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Shivering | 50 Participants |
| Group 1: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pruritus (Incapacitating) | 10 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Shivering | 15 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Shivering (Prevents Daily Activities) | 0 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Malaise | 55 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Erythema (≥ 5 cm) | 2 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Headache | 65 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Swelling | 45 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Myalgia (Prevents Daily Activities) | 5 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pruritus | 32 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Headache (Prevents Daily Activities) | 4 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pain | 148 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Myalgia | 77 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Erythema | 54 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 9 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Fever | 8 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Ecchymosis | 10 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Swelling (≥ 5 cm) | 4 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pain (Incapacitating) | 4 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pruritus (Incapacitating) | 0 Participants |
| Group 2: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Induration | 46 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Headache (Prevents Daily Activities) | 3 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Erythema | 27 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Swelling | 13 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Swelling (≥ 5 cm) | 2 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Induration | 27 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Induration (≥ 5 cm) | 1 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pain | 147 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pain (Incapacitating) | 2 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pruritus | 20 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pruritus (Incapacitating) | 0 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Ecchymosis | 10 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Ecchymosis (≥ 5 cm) | 1 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Headache | 72 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Myalgia | 75 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Myalgia (Prevents Daily Activities) | 0 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Malaise | 50 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 4 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Shivering | 19 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Shivering (Prevents Daily Activities) | 0 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Fever | 9 Participants |
| Group 3: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Ecchymosis | 25 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Fever (> 102.2 ºF) | 1 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Malaise | 54 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pruritus (Incapacitating) | 1 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Fever | 15 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 7 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pruritus | 123 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Pain (Incapacitating) | 2 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Erythema (≥ 5 cm) | 37 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Shivering | 25 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Pain | 145 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Induration | 133 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Induration (≥ 5 cm) | 11 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Shivering (Prevents Daily Activities) | 5 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Headache (Prevents Daily Activities) | 5 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Swelling (≥ 5 cm) | 14 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Myalgia | 68 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Erythema | 183 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Headache | 73 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Injection Site Swelling | 137 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Myalgia (Prevents Daily Activities) | 7 Participants |
| Group 4: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
Secondary
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 28 post-vaccination
Population: Serum antibody geometric mean titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 54.5 Titers |
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 142.8 Titers |
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 78.8 Titers |
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 286.7 Titers |
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 20.1 Titers |
| Group 1: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Post-dose (Day 28; N = 495, 242, 234, 240) | 75.0 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Post-dose (Day 28; N = 495, 242, 234, 240) | 85.7 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 292.0 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 64.8 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 91.3 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 151.7 Titers |
| Group 2: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 21.0 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 126.2 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 69.7 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 268.3 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Post-dose (Day 28; N = 495, 242, 234, 240) | 73.9 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 21.0 Titers |
| Group 3: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 51.2 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 21.8 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Post-dose (Day 28; N = 495, 242, 234, 240) | 72.2 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 137.4 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 290.8 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 56.3 Titers |
| Group 4: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 79.7 Titers |
Secondary
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.
Time frame: Day 28 post-vaccination
Population: Serum antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 64 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 92 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 71 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 98 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 32 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Post-dose (Day 28; N = 495, 242, 234, 240) | 83 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Post-dose (Day 28; N = 495, 242, 234, 240) | 84 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 96 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 70 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 76 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 94 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 32 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 92 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 68 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 98 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Post-dose (Day 28; N = 495, 242, 234, 240) | 79 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 32 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 60 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Pre-dose (Day 0; N = 495, 242, 234, 240) | 33 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | B Post-dose (Day 28; N = 495, 242, 234, 240) | 78 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239) | 90 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239) | 97 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239) | 67 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239) | 71 Percentage of Participants |
Secondary
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.
Time frame: Day 28 post vaccination
Population: Serum antibody titers were assessed in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone ID After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup (N = 495, 242, 234, 240) | 42 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup (N = 495, 242, 234, 239) | 47 Percentage of Participants |
| Group 1: Fluzone ID After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup (N = 495, 242, 234, 239) | 31 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup (N = 495, 242, 234, 240) | 46 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup (N = 495, 242, 234, 239) | 29 Percentage of Participants |
| Group 2: Fluzone IM After Fluzone ID | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup (N = 495, 242, 234, 239) | 40 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup (N = 495, 242, 234, 239) | 42 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup (N = 495, 242, 234, 239) | 26 Percentage of Participants |
| Group 3: Fluzone IM After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup (N = 495, 242, 234, 240) | 42 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup (N = 495, 242, 234, 240) | 35 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup (N = 495, 242, 234, 239) | 44 Percentage of Participants |
| Group 4: Fluzone ID After Fluzone IM | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup (N = 495, 242, 234, 239) | 30 Percentage of Participants |