Influenza, Myxovirus Infection, Orthomyxoviridae Infection
Conditions
Keywords
Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Fluzone®, Adults
Brief summary
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety * To describe the safety profile of subjects who receive of Fluzone ID.
Detailed description
Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.
Interventions
0.1 mL, Intradermal
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 18 to 64 years on the day of vaccination. * Informed consent form signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. * For women 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. * 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. * Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine. * Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion. * 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, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for \>=5 years). * Personal or family history of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | Baseline (Day 0) and 28 Days post-vaccination | The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay |
| Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | 28 Days post-vaccination | The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | Before and 28 Days post-vaccination | The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40. |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Day 0 up to 7 Days post vaccination | Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled from 13 through 30 October 2008 in 50 clinics in the US.
Pre-assignment details
A total of 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone Intradermal (ID) Vaccine Lot 1 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0 | 956 |
| Fluzone Intradermal (ID) Vaccine Lot 2 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0 | 953 |
| Fluzone Intradermal (ID) Vaccine Lot 3 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0 | 955 |
| Fluzone Intramuscular (IM) Vaccine Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0 | 1,428 |
| Total | 4,292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 3 | 5 | 9 |
| Overall Study | Protocol Violation | 5 | 8 | 7 | 6 |
| Overall Study | Serious adverse event | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 8 | 6 | 16 |
Baseline characteristics
| Characteristic | Fluzone Intradermal (ID) Vaccine Lot 2 | Fluzone Intradermal (ID) Vaccine Lot 3 | Fluzone Intradermal (ID) Vaccine Lot 1 | Fluzone Intramuscular (IM) Vaccine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 953 Participants | 955 Participants | 956 Participants | 1428 Participants | 4292 Participants |
| Age, Continuous | 42.8 Years STANDARD_DEVIATION 13.33 | 42.2 Years STANDARD_DEVIATION 13.78 | 42.7 Years STANDARD_DEVIATION 13.41 | 42.5 Years STANDARD_DEVIATION 13.55 | 42.5 Years STANDARD_DEVIATION 13.5175 |
| Region of Enrollment United States | 953 Participants | 955 Participants | 956 Participants | 1428 Participants | 4292 Participants |
| Sex: Female, Male Female | 619 Participants | 594 Participants | 611 Participants | 899 Participants | 2723 Participants |
| Sex: Female, Male Male | 334 Participants | 361 Participants | 345 Participants | 529 Participants | 1569 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 | 716 / 953 | 698 / 951 | 726 / 951 | 749 / 1,421 |
| serious Total, serious adverse events | 17 / 953 | 16 / 951 | 14 / 951 | 20 / 1,421 |
Outcome results
Primary
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Time frame: Baseline (Day 0) and 28 Days post-vaccination
Population: Geometric Mean Titers (GMTs) were analyzed in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Pre-vaccination, N = 862, 855, 860, 1286) | 23.77 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283) | 188.56 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Post-vaccination, N = 861, 856, 860, 1285) | 103.72 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286) | 18.77 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284) | 260.46 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285) | 23.50 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286) | 20.56 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285) | 25.27 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Pre-vaccination, N = 862, 855, 860, 1286) | 25.59 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284) | 234.03 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Post-vaccination, N = 861, 856, 860, 1285) | 102.91 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283) | 185.59 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Post-vaccination, N = 861, 856, 860, 1285) | 100.82 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283) | 206.10 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284) | 246.06 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286) | 18.37 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285) | 25.29 Titer |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Pre-vaccination, N = 862, 855, 860, 1286) | 24.24 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286) | 19.99 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285) | 24.84 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283) | 178.30 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Post-vaccination, N = 861, 856, 860, 1285) | 126.91 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284) | 230.71 Titer |
| Fluzone Intramuscular (IM) Vaccine | Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines | B (Pre-vaccination, N = 862, 855, 860, 1286) | 25.05 Titer |
Primary
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Time frame: 28 Days post-vaccination
Population: Seroprotection was analyzed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup | 61 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup | 47 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup | 76 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup | 59 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup | 45 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup | 73 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup | 77 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup | 63 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup | 47 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H1N1 Serogroup | 61 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | B Serogroup | 54 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | A/H3N2 Serogroup | 75 Percentage of Participants |
Secondary
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Day 0 up to 7 Days post vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 29 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 55 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 480 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 252 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 544 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 13 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 3 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 716 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 447 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Shivering | 71 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 19 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 81 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 125 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (≥ 5 cm) | 8 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 212 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 11 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 554 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Shivering-Prevents daily activities | 7 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 282 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (> 102.2°F) | 2 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 36 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 13 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 202 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 82 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (≥ 5 cm) | 2 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 698 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 118 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 533 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 19 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 449 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 6 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 430 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 10 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 525 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 45 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 40 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (> 102.2°F) | 0 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 279 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 16 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 26 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 229 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 18 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Shivering | 56 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Shivering-Prevents daily activities | 8 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 239 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 40 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 726 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 547 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 17 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Shivering-Prevents daily activities | 6 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 314 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 97 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 260 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 10 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 9 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 41 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 438 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Shivering | 77 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 14 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (≥ 5 cm) | 2 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 7 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 52 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 500 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 120 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 519 Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (> 102.2°F) | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Swelling | 117 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Swelling (≥ 5 cm) | 13 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Myalgia- Prevents daily activities | 19 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Fever | 36 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Induration | 139 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Ecchymosis | 86 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Solicited Fever (> 102.2°F) | 3 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Headache | 422 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Erythema (≥ 5 cm) | 13 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Headache- Prevents daily activities | 22 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Erythema | 184 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Malaise | 309 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Shivering | 87 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grd 3 Solicited Malaise- Prevents daily activities | 25 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Ecchymosis (≥ 5 cm) | 6 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pain (Incapacitating) | 11 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Solicited Myalgia | 430 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pruritus | 129 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Any Injection Site Pain | 749 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Pruritus (Incapacitating) | 0 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Gr 3 Solicited Shivering-Prevents daily activities | 9 Participants |
| Fluzone Intramuscular (IM) Vaccine | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Grade 3 Injection Site Induration (≥ 5 cm) | 7 Participants |
Secondary
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.
Time frame: Before and 28 Days post-vaccination
Population: 4-Fold increase in antibody levels were analyzed in h per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Pre-vaccination) | 39 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Post-vaccination) | 90 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Pre-vaccination) | 31 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Post-vaccination) | 92 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Pre-vaccination) | 38 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 1 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Post-vaccination) | 88 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Post-vaccination) | 88 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Post-vaccination) | 90 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Pre-vaccination) | 40 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Pre-vaccination) | 32 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Post-vaccination) | 90 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 2 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Pre-vaccination) | 42 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Post-vaccination) | 93 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Pre-vaccination) | 30 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Post-vaccination) | 91 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Post-vaccination) | 86 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Pre-vaccination) | 40 Percentage of Participants |
| Fluzone Intradermal (ID) Vaccine Lot 3 | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Pre-vaccination) | 42 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Pre-vaccination) | 41 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | B Serogroup (Post-vaccination) | 89 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Post-vaccination) | 92 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Post-vaccination) | 91 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H1N1 Serogroup (Pre-vaccination) | 39 Percentage of Participants |
| Fluzone Intramuscular (IM) Vaccine | Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM | A/H3N2 Serogroup (Pre-vaccination) | 34 Percentage of Participants |