Influenza
Conditions
Keywords
Influenza, Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),, Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),, Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
Brief summary
The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: * To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit sera from selected subjects 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 formulation recommendations for subsequent influenza vaccines.
Detailed description
Participants 18 to \< 65 years of age on enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE and Serious adverse event information will be collected from Visit 1 to Visit 2. Total duration of participation in the study is approximately 21 days.
Interventions
BIOLOGICALFluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
0.5 mL, Intramuscular
BIOLOGICALFluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
0.1 mL, Intradermal
BIOLOGICALFluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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 2013-2014 formulation of influenza vaccine * Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, 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 Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Day 0 up to Day 21 post-vaccination | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | Day 0 (pre-vaccination) and Day 21 after vaccination | Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay. |
| Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) and Day 21 after vaccination | Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution). |
| Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Day 0 (pre-vaccination) and Day 21 after vaccination | Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination. |
| Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | Day 21 after vaccination | Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 16 to 24 September 2013 at 4 clinic centers in the United States.
Pre-assignment details
A total of 208 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Participants age 18 to \< 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 52 |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Participants age 18 to \< 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) | 52 |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 52 |
| Elderly Fluzone® High Dose, Influenza Vaccine (Group 4) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 52 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Serious Adverse event | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Elderly Fluzone® High Dose, Influenza Vaccine (Group 4) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 52 Participants | 0 Participants | 52 Participants | 104 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 0 Participants | 52 Participants | 0 Participants | 104 Participants |
| Age, Continuous | 46.9 Years STANDARD_DEVIATION 14.7 | 71.5 Years STANDARD_DEVIATION 4.7 | 44.2 Years STANDARD_DEVIATION 15.2 | 72.6 Years STANDARD_DEVIATION 5.2 | 58.75 Years STANDARD_DEVIATION 17.3 |
| Region of Enrollment United States | 52 Participants | 52 Participants | 52 Participants | 52 Participants | 208 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 34 Participants | 33 Participants | 128 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 18 Participants | 19 Participants | 80 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 | 27 / 52 | 30 / 52 | 10 / 52 | 21 / 52 |
| serious Total, serious adverse events | 1 / 52 | 0 / 52 | 1 / 52 | 0 / 52 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time frame: Day 0 up to Day 21 post-vaccination
Population: Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Malaise (N = 52, 52, 52, 52) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Fever (N = 52, 52, 52, 52) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site erythema (N =52, 52,52, 51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Malaise (N = 52, 52, 52, 52) | 11 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Headache (N = 52, 52, 52, 51) | 13 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site pain (N = 52, 52, 52, 52) | 27 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Headache (N = 52, 52, 52, 51) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site pain (N = 52, 52, 52, 52) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Shivering (N = 52, 52, 52, 51) | 3 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site swelling (N = 51, 52, 52, 51) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site swelling (N = 51,52,52,51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Myalgia (N = 52, 52, 52, 51) | 2 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site induration (N = 51, 52, 52, 51) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Shivering (N = 52, 52, 52, 51) | 1 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site induration (N= 51,52,52,51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-ste erythema (N=52,52,52,51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Myalgia (N = 52, 52, 52, 51) | 13 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site ecchymosis (N = 51, 52, 52, 51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site ecchymosis (N= 51,52,52,51) | 0 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Fever (N = 52, 52, 52, 52) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Malaise (N = 52, 52, 52, 52) | 1 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Fever (N = 52, 52, 52, 52) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Shivering (N = 52, 52, 52, 51) | 2 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Malaise (N = 52, 52, 52, 52) | 12 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site swelling (N = 51,52,52,51) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Fever (N = 52, 52, 52, 52) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site pain (N = 52, 52, 52, 52) | 30 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Shivering (N = 52, 52, 52, 51) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site ecchymosis (N= 51,52,52,51) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Headache (N = 52, 52, 52, 51) | 8 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site induration (N = 51, 52, 52, 51) | 4 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Headache (N = 52, 52, 52, 51) | 1 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site ecchymosis (N = 51, 52, 52, 51) | 2 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site erythema (N =52, 52,52, 51) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Myalgia (N = 52, 52, 52, 51) | 16 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-ste erythema (N=52,52,52,51) | 15 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site induration (N= 51,52,52,51) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site swelling (N = 51, 52, 52, 51) | 2 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site pain (N = 52, 52, 52, 52) | 0 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Myalgia (N = 52, 52, 52, 51) | 1 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Headache (N = 52, 52, 52, 51) | 5 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site pain (N = 52, 52, 52, 52) | 10 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site pain (N = 52, 52, 52, 52) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-ste erythema (N=52,52,52,51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site erythema (N =52, 52,52, 51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site swelling (N = 51, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site swelling (N = 51,52,52,51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site induration (N = 51, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site induration (N= 51,52,52,51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site ecchymosis (N = 51, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site ecchymosis (N= 51,52,52,51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Fever (N = 52, 52, 52, 52) | 1 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Fever (N = 52, 52, 52, 52) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Headache (N = 52, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Malaise (N = 52, 52, 52, 52) | 2 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Malaise (N = 52, 52, 52, 52) | 0 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Myalgia (N = 52, 52, 52, 51) | 6 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Myalgia (N = 52, 52, 52, 51) | 1 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Shivering (N = 52, 52, 52, 51) | 2 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Shivering (N = 52, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site ecchymosis (N= 51,52,52,51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site ecchymosis (N = 51, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Shivering (N = 52, 52, 52, 51) | 4 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Malaise (N = 52, 52, 52, 52) | 1 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site induration (N= 51,52,52,51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site induration (N = 51, 52, 52, 51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site pain (N = 52, 52, 52, 52) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Myalgia (N = 52, 52, 52, 51) | 10 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site swelling (N = 51,52,52,51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site swelling (N = 51, 52, 52, 51) | 1 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-site pain (N = 52, 52, 52, 52) | 21 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Myalgia (N = 52, 52, 52, 51) | 1 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Injection-site erythema (N =52, 52,52, 51) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Headache (N = 52, 52, 52, 51) | 8 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Injection-ste erythema (N=52,52,52,51) | 2 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Headache (N = 52, 52, 52, 51) | 1 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Fever (N = 52, 52, 52, 52) | 0 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Fever (N = 52, 52, 52, 52) | 2 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Grade 3 Shivering (N = 52, 52, 52, 51) | 3 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Malaise (N = 52, 52, 52, 52) | 8 Participants |
Secondary
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.
Time frame: Day 21 after vaccination
Population: Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Victoria) | 4.74 Titer Ratio |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H1N1 | 5.58 Titer Ratio |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Yamagata) | 3.62 Titer Ratio |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H3N2 | 6.42 Titer Ratio |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Yamagata) | 3.50 Titer Ratio |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H1N1 | 5.77 Titer Ratio |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H3N2 | 3.92 Titer Ratio |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Victoria) | NA Titer Ratio |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Yamagata) | 1.95 Titer Ratio |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Victoria) | 1.86 Titer Ratio |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H1N1 | 2.89 Titer Ratio |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H3N2 | 2.40 Titer Ratio |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H3N2 | 6.10 Titer Ratio |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Yamagata) | 3.28 Titer Ratio |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | A/H1N1 | 3.66 Titer Ratio |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | B (Victoria) | NA Titer Ratio |
Secondary
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 21 after vaccination
Population: Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (pre-vaccination) | 82.3 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (post-vaccination) | 514 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (pre-vaccination) | 77.2 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (post-vaccination) | 563 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; pre-vaccination) | 34.2 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; post-vaccination) | 142 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; pre-vaccination) | 24.7 Titers |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; post-vaccination) | 134 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; post-vaccination) | 147 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; pre-vaccination) | 38.2 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (post-vaccination) | 471 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; post-vaccination) | NA Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; pre-vaccination) | NA Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (post-vaccination) | 531 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (pre-vaccination) | 128 Titers |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (pre-vaccination) | 74.3 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; pre-vaccination) | 34.2 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (pre-vaccination) | 185 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (post-vaccination) | 449 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; pre-vaccination) | 32.4 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; post-vaccination) | 67.5 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; post-vaccination) | 67.5 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (pre-vaccination) | 54.7 Titers |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (post-vaccination) | 163 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (pre-vaccination) | 104 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H3N2 (post-vaccination) | 636 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (post-vaccination) | 345 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | A/H1N1 (pre-vaccination) | 91.0 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; pre-vaccination) | 36.1 Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; post-vaccination) | NA Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Victoria; pre-vaccination) | NA Titers |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | B (Yamagata; post-vaccination) | 122 Titers |
Secondary
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 after vaccination
Population: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 | 23 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 | 27 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata) | 19 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B Victoria | 25 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 | 26 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata) | 18 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 | 19 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B Victoria | NA Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata) | 5 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 | 17 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B Victoria | 9 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 | 15 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 | 25 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 | 33 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B Victoria | NA Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata) | 21 Participants |
Secondary
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).
Time frame: Day 0 (pre-vaccination) and Day 21 after vaccination
Population: Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (pre-vaccination) | 34 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (post-vaccination) | 47 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination) | 33 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (post-vaccination) | 48 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; pre-vaccination) | 28 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; post-vaccination) | 44 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; pre-vaccination) | 23 Participants |
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; post-vaccination) | 44 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; post-vaccination) | 49 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; pre-vaccination) | 31 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (post-vaccination) | 52 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; post-vaccination) | NA Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; pre-vaccination) | NA Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (post-vaccination) | 52 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination) | 41 Participants |
| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (pre-vaccination) | 36 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; pre-vaccination) | 32 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination) | 47 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (post-vaccination) | 50 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; pre-vaccination) | 26 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; post-vaccination) | 45 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; post-vaccination) | 42 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (pre-vaccination) | 32 Participants |
| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (post-vaccination) | 47 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (pre-vaccination) | 41 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H3N2 (post-vaccination) | 51 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (post-vaccination) | 51 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | A/H1N1 (pre-vaccination) | 39 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; pre-vaccination) | 29 Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; post-vaccination) | NA Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Victoria; pre-vaccination) | NA Participants |
| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | B (Yamagata; post-vaccination) | 50 Participants |