Influenza
Conditions
Keywords
Influenza, Fluzone® Quadrivalent, Influenza Vaccine, Fluzone® Intradermal, Influenza Vaccine, Fluzone® High-Dose, Influenza Vaccine
Brief summary
The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Objectives: * To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2014-2015 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.
Detailed description
Adults 18 to \< 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.
Interventions
BIOLOGICALFluzone® Quadrivalent vaccine, 2014-2015 formulation
0.5 mL, Intramuscular
BIOLOGICALFluzone I®ntradermal vaccine, 2014-2015 formulation
0.1 mL, Intradermal
BIOLOGICALFluzone High Dose vaccine, 2014-2015 formulation
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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 2014-2015 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, 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 an 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 an Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 0 up to Day 7 post-vaccination | Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥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 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | Day 0 (pre-vaccination) and Day 21 post-vaccination | Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. |
| Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | Day 0 (pre-vaccination) and Day 21 post-vaccination | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution \[dil\]) at pre-vaccination and 21 days after vaccination. |
| Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Day 21 post-vaccination | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination. |
| Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | Day 21 post-vaccination | Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.
Pre-assignment details
A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | 50 |
| Group 2 Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. | 54 |
| Group 3 Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | 52 |
| Group 4 Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. | 52 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2 | Group 3 | Group 1 | 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 | 54 Participants | 0 Participants | 50 Participants | 0 Participants | 104 Participants |
| Age, Continuous Age Continuous | 48.0 Years STANDARD_DEVIATION 12.1 | 73.9 Years STANDARD_DEVIATION 5 | 44.8 Years STANDARD_DEVIATION 14.9 | 72.2 Years STANDARD_DEVIATION 5.4 | 59.8 Years STANDARD_DEVIATION 16.8 |
| Region of Enrollment United States | 54 Participants | 52 Participants | 50 Participants | 52 Participants | 208 Participants |
| Sex: Female, Male Female | 33 Participants | 32 Participants | 31 Participants | 31 Participants | 127 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 19 Participants | 21 Participants | 81 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 | 26 / 49 | 28 / 54 | 19 / 52 | 21 / 52 |
| serious Total, serious adverse events | 0 / 49 | 0 / 54 | 1 / 52 | 0 / 52 |
Outcome results
Primary
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Pain | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Ecchymosis | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Pain | 53.1 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 4.1 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Induration | 6.1 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Induration | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Swelling | 4.1 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 28.6 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Swelling | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Ecchymosis | 2.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Erythema | 6.1 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 16.3 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0.0 Percentage of participants |
| Group 1 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 26.5 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Pain | 1.9 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 25.9 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Swelling | 22.2 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Pain | 51.9 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 1.9 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Induration | 18.5 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Swelling | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 1.9 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 9.3 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 18.5 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 27.8 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Ecchymosis | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Erythema | 35.2 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Ecchymosis | 5.6 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Induration | 0 Percentage of participants |
| Group 2 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 1.9 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Induration | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Induration | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Ecchymosis | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Ecchymosis | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 17.3 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 9.6 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 23.1 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 1.9 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Pain | 36.5 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Pain | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Erythema | 3.8 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Swelling | 5.8 Percentage of participants |
| Group 3 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Swelling | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Malaise | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Malaise | 15.4 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Swelling | 5.8 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Pain | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Headache | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Headache | 25.0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Induration | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Erythema | 7.7 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Fever | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Fever | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Induration | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection site Erythema | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Ecchymosis | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Shivering | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Ecchymosis | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Shivering | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Myalgia | 1.9 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Myalgia | 28.8 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Grade 3 Injection-site Swelling | 0 Percentage of participants |
| Group 4 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site Pain | 40.4 Percentage of participants |
Secondary
Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 21 post-vaccination
Population: Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H1N1 (N=49,52,52,52) | 4.32 Titer ratios |
| Group 1 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H3N2 (N=49,53,52,52) | 4.26 Titer ratios |
| Group 1 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Yamagata) (N=49,53,52,52) | 3.08 Titer ratios |
| Group 1 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Victoria) (N=49,0,52,0) | 4.39 Titer ratios |
| Group 2 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H3N2 (N=49,53,52,52) | 4.24 Titer ratios |
| Group 2 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Yamagata) (N=49,53,52,52) | 2.70 Titer ratios |
| Group 2 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Victoria) (N=49,0,52,0) | NA Titer ratios |
| Group 2 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H1N1 (N=49,52,52,52) | 3.92 Titer ratios |
| Group 3 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Yamagata) (N=49,53,52,52) | 1.83 Titer ratios |
| Group 3 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H3N2 (N=49,53,52,52) | 2.08 Titer ratios |
| Group 3 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Victoria) (N=49,0,52,0) | 2.08 Titer ratios |
| Group 3 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H1N1 (N=49,52,52,52) | 1.91 Titer ratios |
| Group 4 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Victoria) (N=49,0,52,0) | NA Titer ratios |
| Group 4 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H3N2 (N=49,53,52,52) | 2.48 Titer ratios |
| Group 4 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | A/H1N1 (N=49,52,52,52) | 2.25 Titer ratios |
| Group 4 | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | B (Yamagata) (N=49,53,52,52) | 2.14 Titer ratios |
Secondary
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Geometric mean titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 1836 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 139 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | 1119 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 153 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 613 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Pre-vaccination (N=49,0,52,0) | 252 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 707 Titers (1/dilution) |
| Group 1 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 596 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 632 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Pre-vaccination (N=49,0,52,0) | NA Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | NA Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 148 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 147 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 648 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 471 Titers (1/dilution) |
| Group 2 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 1272 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 168 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 864 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 471 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | 568 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 288 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 148 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Pre-vaccination (N=49,0,52,0) | 273 Titers (1/dilution) |
| Group 3 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 349 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | NA Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 171 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 386 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 275 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 680 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 465 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 994 Titers (1/dilution) |
| Group 4 | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | B (Victoria); Pre-vaccination (N=49,0,52,0) | NA Titers (1/dilution) |
Secondary
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination.
Time frame: Day 21 post-vaccination
Population: Seroconversion was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N=49,52,52,52) | 34.7 Percentage of participants |
| Group 1 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N=49,53,52,52) | 38.8 Percentage of participants |
| Group 1 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Yamagata) (N=49,53,52,52) | 28.6 Percentage of participants |
| Group 1 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Victoria) (N=49,0,52,0) | 51.0 Percentage of participants |
| Group 2 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N=49,53,52,52) | 39.6 Percentage of participants |
| Group 2 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Yamagata) (N=49,53,52,52) | 28.3 Percentage of participants |
| Group 2 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Victoria) (N=49,0,52,0) | NA Percentage of participants |
| Group 2 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N=49,52,52,52) | 42.3 Percentage of participants |
| Group 3 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Yamagata) (N=49,53,52,52) | 15.4 Percentage of participants |
| Group 3 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N=49,53,52,52) | 23.1 Percentage of participants |
| Group 3 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Victoria) (N=49,0,52,0) | 23.1 Percentage of participants |
| Group 3 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N=49,52,52,52) | 15.4 Percentage of participants |
| Group 4 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Victoria) (N=49,0,52,0) | NA Percentage of participants |
| Group 4 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H3N2 (N=49,53,52,52) | 26.9 Percentage of participants |
| Group 4 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | A/H1N1 (N=49,52,52,52) | 28.8 Percentage of participants |
| Group 4 | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | B (Yamagata) (N=49,53,52,52) | 21.2 Percentage of participants |
Secondary
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution \[dil\]) at pre-vaccination and 21 days after vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Seroprotection was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 77.6 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 98.0 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 81.6 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 98.0 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 98.0 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | 100.0 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 1 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Pre-vaccination (n=49,0,52,0) | 91.8 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 98.1 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 84.6 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Pre-vaccination (n=49,0,52,0) | NA Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 83.0 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | NA Percentage of participants |
| Group 2 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | 100.0 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 82.7 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 94.2 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 90.4 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 92.3 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 96.2 Percentage of participants |
| Group 3 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Pre-vaccination (n=49,0,52,0) | 94.2 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Pre-vaccination (N=49,53,52,52) | 96.2 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H3N2; Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Pre-vaccination (n=49,0,52,0) | NA Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Post-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Victoria); Post-vaccination (N=49,0,52,0) | NA Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | A/H1N1; Pre-vaccination (N=49,52,52,52) | 90.4 Percentage of participants |
| Group 4 | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | B (Yamagata); Pre-vaccination (N=49,53,52,52) | 100.0 Percentage of participants |