Influenza
Conditions
Keywords
Influenza, Influenza virus vaccine, Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation, Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation, Trivalent Inactivated Influenza Vaccine, Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation
Brief summary
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective: * To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
Detailed description
Participants 18 to \< 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.
Interventions
BIOLOGICALInfluenza Virus Vaccine: Fluzone® 2012-2013 Formulation
0.5 mL, Intramuscular
BIOLOGICALInfluenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation
0.1 mL, Intradermal
BIOLOGICALInfluenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is ≥ 18 years of age on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* History of serious adverse reaction to any influenza vaccine * Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study * Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator * Prior vaccination with any 2012 - 2013 formulation of influenza vaccine * Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) * Receipt of immune globulins, blood, or blood-derived products in the past 3 months * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator * Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) * Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine * Personal history of Guillain-Barré syndrome * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the subject * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) up to Day 21 post-vaccination | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. |
| Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil). |
| Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. |
| Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of \<1:10. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.
Pre-assignment details
A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone® Vaccine (Group 1) Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly | 50 |
| Fluzone® Intradermal Vaccine (Group 2) Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally | 50 |
| Fluzone® Vaccine (Group 3) Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly | 51 |
| Fluzone® High-Dose Vaccine (Group 4) Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly | 49 |
| Total | 200 |
Baseline characteristics
| Characteristic | Fluzone® Intradermal Vaccine (Group 2) | Fluzone® Vaccine (Group 3) | Fluzone® Vaccine (Group 1) | Fluzone® High-Dose Vaccine (Group 4) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 51 Participants | 0 Participants | 49 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 0 Participants | 50 Participants | 0 Participants | 100 Participants |
| Age Continuous | 40.5 Years STANDARD_DEVIATION 14.2 | 73.3 Years STANDARD_DEVIATION 5.7 | 43.4 Years STANDARD_DEVIATION 13.6 | 72.2 Years STANDARD_DEVIATION 5.2 | 57.4 Years STANDARD_DEVIATION 18.7 |
| Region of Enrollment United States | 50 Participants | 51 Participants | 50 Participants | 49 Participants | 200 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 31 Participants | 35 Participants | 127 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 19 Participants | 14 Participants | 73 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 | 12 / 50 | 20 / 50 | 13 / 51 | 19 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 2 / 51 | 0 / 49 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Swelling | 1 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Ecchymosis | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Erythema | 1 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Pain | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 10 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 10 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 1 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Induration | 1 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Pain | 12 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 2 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Ecchymosis | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 4 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3Injection site Induration | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 11 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 11 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Swelling | 9 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Pain | 20 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 12 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Pain | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Erythema | 16 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3Injection site Induration | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 1 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Ecchymosis | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Induration | 4 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 10 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 4 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Ecchymosis | 1 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Induration | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Ecchymosis | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 11 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 10 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 13 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 2 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 4 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Pain | 12 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Pain | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Erythema | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Swelling | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3Injection site Induration | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Ecchymosis | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Ecchymosis | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Swelling | 1 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 3 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 7 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 7 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Induration | 1 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 7 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Ecchymosis | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3Injection site Induration | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Erythema | 1 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Pain | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection site Pain | 19 Participants |
Other Pre-specified
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) up to Day 21 post-vaccination
Population: Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 28.3 Titers |
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 1068 Titers |
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 29.1 Titers |
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 460 Titers |
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 17.9 Titers |
| Fluzone® Vaccine (Group 1) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 169 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 129 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 599 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 30.7 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 23.6 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 1473 Titers |
| Fluzone® Intradermal Vaccine (Group 2) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 20.9 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 246 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 68.5 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 264 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 35.2 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 13.7 Titers |
| Fluzone® Vaccine (Group 3) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 58.6 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 18.7 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 60.1 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 369 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 392 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 81.8 Titers |
| Fluzone® High-Dose Vaccine (Group 4) | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 78.2 Titers |
Other Pre-specified
Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine (Group 1) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N = 46, 46, 49, 46) | 43 Participants |
| Fluzone® Vaccine (Group 1) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (N = 45, 46, 49, 46) | 36 Participants |
| Fluzone® Vaccine (Group 1) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N = 45, 46, 49, 46) | 34 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N = 46, 46, 49, 46) | 43 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (N = 45, 46, 49, 46) | 33 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N = 45, 46, 49, 46) | 39 Participants |
| Fluzone® Vaccine (Group 3) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N = 45, 46, 49, 46) | 19 Participants |
| Fluzone® Vaccine (Group 3) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N = 46, 46, 49, 46) | 21 Participants |
| Fluzone® Vaccine (Group 3) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (N = 45, 46, 49, 46) | 13 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N = 46, 46, 49, 46) | 26 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (N = 45, 46, 49, 46) | 16 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N = 45, 46, 49, 46) | 28 Participants |
Other Pre-specified
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of \<1:10.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 18 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination; N = 46, 46, 49, 46) | 17 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 0 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 12 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 0 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 1 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination; N = 46, 46, 49, 46) | 19 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 17 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 9 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 1 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 1 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination; N = 46, 46, 49, 46) | 6 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 4 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 0 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 17 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 6 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 13 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 0 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 6 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 1 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination; N = 46, 46, 49, 46) | 2 Participants |
Other Pre-specified
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 9 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 22 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 45 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 44 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 46 Participants |
| Fluzone® Vaccine (Group 1) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 22 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 40 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 23 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 46 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 15 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 45 Participants |
| Fluzone® Intradermal Vaccine (Group 2) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 15 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 46 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 49 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 26 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 32 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 8 Participants |
| Fluzone® Vaccine (Group 3) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 33 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Pre-vaccination; N = 46, 46, 49, 46) | 13 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) | 45 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) | 45 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) | 33 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Post-vaccination; N = 45, 47, 49, 46) | 33 Participants |
| Fluzone® High-Dose Vaccine (Group 4) | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) | 31 Participants |