Influenza
Conditions
Keywords
Influenza, Fluzone® Quadrivalent, Influenza Vaccine, Fluzone® Intradermal Quadrivalent, Influenza Vaccine, Fluzone® High Dose, Influenza Vaccine
Brief summary
The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: \- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2015-2016 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 Quadrivalent, 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) Committee for Propriety Medicinal Products (CPMP) - CHMP NfG CPMP/BWP/214/96.
Detailed description
Adults age 18 to \< 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone Intradermal Quadrivalent vaccine and adults age ≥ 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. All subjects will receive a single dose of their randomly assigned vaccine. They will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse reactions will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2.
Interventions
BIOLOGICALFluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
0.5 mL, Intramuscular (IM)
BIOLOGICALFluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
0.1 mL, Intradermal
BIOLOGICALFluzone High-Dose vaccine, 2015-2016 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 2015-2016 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 Quadrivalent, 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 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 |
|---|---|---|
| Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Day 0 (pre-vaccination) and 21 days post-vaccination | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. |
| Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Day 0 (Pre-vaccination) and 21 days post-vaccination | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination. |
| Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | 21 days post-vaccination | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination. |
| Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | 21 days post-vaccination | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States.
Pre-assignment details
A total of 208 participants who met all of the inclusion criteria and no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | 52 |
| Fluzone Quadrivalent Intradermal Vaccine Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine | 52 |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | 53 |
| Fluzone High-Dose Vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine | 51 |
| Total | 208 |
Baseline characteristics
| Characteristic | Fluzone Quadrivalent Intradermal Vaccine | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Fluzone High-Dose Vaccine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 53 Participants | 0 Participants | 51 Participants | 104 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 0 Participants | 52 Participants | 0 Participants | 104 Participants |
| Age, Continuous | 43.4 Years STANDARD_DEVIATION 14.7 | 72.8 Years STANDARD_DEVIATION 5.2 | 46.4 Years STANDARD_DEVIATION 13.5 | 74.2 Years STANDARD_DEVIATION 6.2 | 59.2 Years STANDARD_DEVIATION 17.9 |
| Region of Enrollment United States | 52 Participants | 53 Participants | 52 Participants | 51 Participants | 208 Participants |
| Sex: Female, Male Female | 39 Participants | 28 Participants | 37 Participants | 26 Participants | 130 Participants |
| Sex: Female, Male Male | 13 Participants | 25 Participants | 15 Participants | 25 Participants | 78 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 | 29 / 53 | 29 / 51 | 15 / 53 | 22 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 | 0 / 53 | 1 / 51 |
Outcome results
Primary
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set.
Time frame: Day 0 up to Day 7 post-vaccination
Population: The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to \< 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) group in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Swelling (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Myalgia (N=53, 51, 53, 51) | 15 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Headache (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Shivering (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Swelling (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Erythema (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Pain (N=53, 51, 53, 51) | 29 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Malaise (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Induration (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Shivering (N=53, 51, 53, 51) | 6 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Pain (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Malaise (N=53, 51, 53, 51) | 7 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Myalgia (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Headache (N=53, 51, 53, 51) | 13 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Ecchymosis (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Ecchymosis (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Induration (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Erythema (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Induration (N=53, 51, 53, 51) | 6 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Erythema (N=53, 51, 53, 51) | 17 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Swelling (N=53, 51, 53, 51) | 10 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Swelling (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Induration (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Headache (N=53, 51, 53, 51) | 12 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Malaise (N=53, 51, 53, 51) | 11 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Myalgia (N=53, 51, 53, 51) | 11 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Myalgia (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Pain (N=53, 51, 53, 51) | 29 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Pain (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Erythema (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Ecchymosis (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Ecchymosis (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Headache (N=53, 51, 53, 51) | 2 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Malaise (N=53, 51, 53, 51) | 2 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Shivering (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Shivering (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Erythema (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Erythema (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Malaise (N=53, 51, 53, 51) | 10 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Swelling (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Swelling (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Myalgia (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Ecchymosis (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Ecchymosis (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Induration (N=53,51,53,51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Headache (N=53, 51, 53, 51) | 9 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Shivering (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Headache (N=53, 51, 53, 51) | 1 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Induration (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Shivering (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Malaise (N=53, 51, 53, 51) | 0 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Myalgia (N=53, 51, 53, 51) | 9 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Pain (N=53, 51, 53, 51) | 15 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Pain (N=53, 51, 53, 51) | 1 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Pain (N=53, 51, 53, 51) | 22 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Headache (N=53, 51, 53, 51) | 6 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Erythema (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Myalgia (N=53, 51, 53, 51) | 13 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Malaise (N=53, 51, 53, 51) | 6 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Headache (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Induration (N=53, 51, 53, 51) | 1 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Ecchymosis (N=53,51,53,51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Pain (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Ecchymosis (N=53, 51, 53, 51) | 2 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Swelling (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Myalgia (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Erythema (N=53, 51, 53, 51) | 7 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Injection-site Induration (N=53,51,53,51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Shivering (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Grade 3 Malaise (N=53, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Fever (N=52, 51, 53, 51) | 0 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Injection-site Swelling (N=53, 51, 53, 51) | 3 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Shivering (N=53, 51, 53, 51) | 0 Participants |
Secondary
Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Time frame: 21 days post-vaccination
Population: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 4.74 Titer ratio |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 2.72 Titer ratio |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 19.4 Titer ratio |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 5.29 Titer ratio |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 2.87 Titer ratio |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 16.4 Titer ratio |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 3.18 Titer ratio |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 3.58 Titer ratio |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 7.49 Titer ratio |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 1.97 Titer ratio |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 1.77 Titer ratio |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 2.11 Titer ratio |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 5.07 Titer ratio |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | NA Titer ratio |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 15.2 Titer ratio |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 3.52 Titer ratio |
Secondary
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Time frame: Day 0 (pre-vaccination) and 21 days post-vaccination
Population: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 234 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 764 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 186 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 49.4 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 1237 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 881 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 274 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post-vaccination (N=51,50,53,51) | 1051 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 1099 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 290 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 844 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 631 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post-vaccination (N=51,50,53,51) | 1033 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 61.9 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 307 Titers (1/dilutions) |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 196 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post-vaccination (N=51,50,53,51) | 379 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 355 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 160 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 178 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 208 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 283 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 438 Titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 48.0 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | NA Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 471 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 62.2 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 324 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 50.1 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post-vaccination (N=51,50,53,51) | 769 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 134 Titers (1/dilutions) |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | NA Titers (1/dilutions) |
Secondary
Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.
Time frame: 21 days post-vaccination
Population: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 29 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 27 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 15 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 44 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 17 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 24 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 42 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 15 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 35 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | 9 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 9 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 13 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1 (N=51,50,53,51) | 27 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata (N=51,50,53,51) | 23 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria (N=51,50,53,0) | NA Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2 (N=51,50,53,51) | 44 Participants |
Secondary
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.
Time frame: Day 0 (Pre-vaccination) and 21 days post-vaccination
Population: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 51 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 51 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 45 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 41 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 32 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 47 Participants |
| Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 51 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 35 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 47 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 49 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 49 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 48 Participants |
| Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 36 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 47 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | 53 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 51 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 53 Participants |
| Fluzone Quadrivalent Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | 49 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Pre-vaccination (N=51,50,53,0) | NA Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Victoria; Post-vaccination (N=51,50,53,0) | NA Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Pre-vaccination (N=51,50,53,51) | 28 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Post-vaccination (N=51,50,53,51) | 50 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H3N2; Post vaccination (N=51,50,53,51) | 51 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Pre-vaccination (N=51,50,53,51) | 48 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | B Yamagata; Post-vaccination (N=51,50,53,51) | 51 Participants |
| Fluzone High-Dose Vaccine (≥ 65 Years) | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | A/H1N1; Pre-vaccination (N=51,50,53,51) | 38 Participants |