Influenza, Myxovirus Infection, Orthomyxovirus Infection
Conditions
Keywords
Influenza, Orthomyxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
Brief summary
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Detailed description
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
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
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Aged ≥ 65 years on the day of vaccination * Enrolled in and completed study FID29 and received the correct vaccine 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 * Subject is medically stable.
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 * 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 * Known human immunodeficiency virus (HIV), hepatitis B (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 intramuscular (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, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years). * Personal or family history of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Days 0 through 7 post vaccination | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Day 0 and Day 28 post-vaccination | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. |
| Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Days 0 and 28 post-vaccination | Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. |
| Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose 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
United States
Participant flow
Recruitment details
Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.
Pre-assignment details
A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1a: Fluzone ID After Fluzone ID Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | 295 |
| Group 1b: Fluzone IM After Fluzone ID Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | 98 |
| Group 2a: Fluzone IM After Fluzone IM Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | 105 |
| Group 2b: Fluzone ID After Fluzone IM Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | 108 |
| Group 3: Fluzone HD After Fluzone HD Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) | 201 |
| Total | 807 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Serious Adverse Event | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 1a: Fluzone ID After Fluzone ID | Group 3: Fluzone HD After Fluzone HD | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 98 Participants | 105 Participants | 108 Participants | 295 Participants | 201 Participants | 807 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.2 Years STANDARD_DEVIATION 5.97 | 73.0 Years STANDARD_DEVIATION 5.37 | 74.3 Years STANDARD_DEVIATION 5.11 | 73.9 Years STANDARD_DEVIATION 5.99 | 73.5 Years STANDARD_DEVIATION 5.74 | 73.8 Years STANDARD_DEVIATION 5.74 |
| Region of Enrollment United States | 98 participants | 105 participants | 108 participants | 295 participants | 201 participants | 807 participants |
| Sex: Female, Male Female | 54 Participants | 58 Participants | 61 Participants | 169 Participants | 117 Participants | 459 Participants |
| Sex: Female, Male Male | 44 Participants | 47 Participants | 47 Participants | 126 Participants | 84 Participants | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 239 / 292 | 42 / 98 | 54 / 105 | 86 / 107 | 123 / 200 |
| serious Total, serious adverse events | 10 / 295 | 3 / 98 | 6 / 105 | 3 / 108 | 10 / 201 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Days 0 through 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 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Shivering (Prevents daily activities) | 0 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Fever (>102.2 ºF) | 0 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Erythema | 207 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Headache | 39 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Malaise | 31 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pain | 68 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Erythema (≥ 5 cm) | 34 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Swelling | 127 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Swelling (≥ 5 cm) | 9 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Induration | 133 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Induration (≥ 5 cm) | 5 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pain (Incapacitating) | 2 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Ecchymosis | 27 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Ecchymosis (≥ 5 cm) | 1 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Myalgia | 35 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pruritus | 99 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pruritus (Incapacitating) | 6 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Shivering | 12 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Fever | 9 Participants |
| Group 1a: Fluzone ID After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Shivering | 2 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Fever | 1 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Swelling | 4 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pruritus | 3 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Induration | 6 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Shivering (Prevents daily activities) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pruritus (Incapacitating) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Ecchymosis | 2 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Fever (>102.2 ºF) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Myalgia | 18 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Headache | 14 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Erythema | 18 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Malaise | 7 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Erythema (≥ 5 cm) | 1 Participants |
| Group 1b: Fluzone IM After Fluzone ID | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pain | 18 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pruritus (Incapacitating) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Ecchymosis | 5 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Swelling | 3 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pain | 23 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Fever (>102.2 ºF) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Shivering (Prevents daily activities) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Malaise | 18 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Erythema | 9 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Induration | 6 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Headache | 15 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pruritus | 6 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Induration (≥ 5 cm) | 0 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Fever | 1 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Myalgia | 25 Participants |
| Group 2a: Fluzone IM After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Shivering | 5 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Swelling | 44 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pain | 31 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pain (Incapacitating) | 2 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Erythema | 71 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Erythema (≥ 5 cm) | 7 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pruritus | 38 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Swelling (≥ 5 cm) | 3 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Induration | 50 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Induration (≥ 5 cm) | 1 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Ecchymosis | 11 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pruritus (Incapacitating) | 1 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Fever | 4 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Fever (>102.2 ºF) | 0 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Headache | 17 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Malaise | 16 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Myalgia | 22 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Shivering | 7 Participants |
| Group 2b: Fluzone ID After Fluzone IM | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Shivering (Prevents daily activities) | 0 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pruritus (Incapacitating) | 0 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pruritus | 20 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Pain (Incapacitating) | 1 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Malaise (Prevents daily activities) | 2 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Ecchymosis (≥ 5 cm) | 0 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Ecchymosis | 6 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Induration (≥ 5 cm) | 1 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Pain | 91 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Myalgia | 48 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Induration | 18 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Swelling (≥ 5 cm) | 5 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Swelling | 23 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Erythema (≥ 5 cm) | 7 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Solicited Injection site Erythema | 34 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Shivering (Prevents daily activities) | 0 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Headache | 45 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Grade 3 Fever (>102.2 ºF) | 0 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Shivering | 9 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Malaise | 36 Participants |
| Group 3: Fluzone HD After Fluzone HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Any Fever | 7 Participants |
Secondary
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Serum antibody titers for the 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 titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) | 28.7 Titers |
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) | 75.0 Titers |
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) | 30.8 Titers |
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) | 244 Titers |
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Pre Dose (n = 273, 94, 100, 102, 186 | 22.8 Titers |
| Group 1a: Fluzone ID After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Post Dose (n = 273, 94, 100, 102, 185) | 54.3 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Pre Dose (n = 273, 94, 100, 102, 186 | 18.9 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Post Dose (n = 273, 94, 100, 102, 185) | 51.4 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) | 23.5 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) | 28.7 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) | 212 Titers |
| Group 1b: Fluzone IM After Fluzone ID | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) | 59.6 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) | 257 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Pre Dose (n = 273, 94, 100, 102, 186 | 21.8 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) | 27.3 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) | 24.5 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) | 72.4 Titers |
| Group 2a: Fluzone IM After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Post Dose (n = 273, 94, 100, 102, 185) | 60.4 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) | 273 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) | 73.5 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) | 28.1 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Post Dose (n = 273, 94, 100, 102, 185) | 51.1 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Pre Dose (n = 273, 94, 100, 102, 186 | 21.9 Titers |
| Group 2b: Fluzone ID After Fluzone IM | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) | 20.8 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Pre Dose (n = 273, 94, 100, 102, 186 | 22.3 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) | 36.6 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) | 113 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | B Post Dose (n = 273, 94, 100, 102, 185) | 78.2 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) | 454 Titers |
| Group 3: Fluzone HD After Fluzone HD | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) | 28.7 Titers |
Secondary
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose 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 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 (N = 273, 94, 100, 102, 185) | 31 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B (N = 273, 94, 100, 102, 185) | 24 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H2N3 (N = 273, 94, 100, 102, 186) | 73 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H2N3 (N = 273, 94, 100, 102, 186) | 64 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 (N = 273, 94, 100, 102, 185) | 28 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B (N = 273, 94, 100, 102, 185) | 31 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H2N3 (N = 273, 94, 100, 102, 186) | 76 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 (N = 273, 94, 100, 102, 185) | 31 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B (N = 273, 94, 100, 102, 185) | 33 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 (N = 273, 94, 100, 102, 185) | 44 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B (N = 273, 94, 100, 102, 185) | 26 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H2N3 (N = 273, 94, 100, 102, 186) | 75 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H2N3 (N = 273, 94, 100, 102, 186) | 84 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 (N = 273, 94, 100, 102, 185) | 47 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B (N = 273, 94, 100, 102, 185) | 41 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
Time frame: Days 0 and 28 post-vaccination
Population: Serum antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 0, Pre-dose) | 49 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 0, Pre-dose) | 40 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 28, Post-dose) | 93 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 28, Post-dose) | 80 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 28, Post-dose) | 73 Percentage of Participants |
| Group 1a: Fluzone ID After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 0, Pre-dose) | 36 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 0, Pre-dose) | 40 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 28, Post-dose) | 69 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 28, Post-dose) | 86 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 28, Post-dose) | 72 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 0, Pre-dose) | 36 Percentage of Participants |
| Group 1b: Fluzone IM After Fluzone ID | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 0, Pre-dose) | 29 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 0, Pre-dose) | 32 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 28, Post-dose) | 75 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 28, Post-dose) | 80 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 0, Pre-dose) | 38 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 0, Pre-dose) | 39 Percentage of Participants |
| Group 2a: Fluzone IM After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 28, Post-dose) | 94 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 0, Pre-dose) | 32 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 28, Post-dose) | 91 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 0, Pre-dose) | 26 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 28, Post-dose) | 81 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 28, Post-dose) | 66 Percentage of Participants |
| Group 2b: Fluzone ID After Fluzone IM | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 0, Pre-dose) | 48 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 28, Post-dose) | 83 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 0, Pre-dose) | 41 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H1N1 Serogroup - (Day 28, Post-dose) | 88 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 0, Pre-dose) | 50 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | A/H3N2 Serogroup - (Day 28, Post-dose) | 98 Percentage of Participants |
| Group 3: Fluzone HD After Fluzone HD | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | B Serogroup - (Day 0, Pre-dose) | 36 Percentage of Participants |