Pain, Quality of Life, Injection Site Reaction, Side Effect of Drug, Adverse Drug Event
Conditions
Keywords
influenza vaccine, fever following vaccination, pain following vaccination, quality of life
Brief summary
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.
Detailed description
Full Analysis Population 1: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary. Full Analysis Population 2: Defined as all subjects who are randomized and vaccinated. Immunogenicity Population: Defined as subjects who received vaccine, provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
Interventions
BIOLOGICALFLUAD®
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICALFluzone® High-Dose
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Sponsors
Centers for Disease Control and Prevention
Boston Medical Center
Children's Hospital Medical Center, Cincinnati
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Subject, study coordinators, and investigators will be blinded to the type of flu vaccine administered. Only the vaccinator will be unblinded.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Persons aged ≥65 years, living in the community 2. Intention of receiving IIV vaccine based on ACIP-CDC guidelines 3. Willing to provide written informed consent prior to initiation of any study procedures 4. Able to speak English 5. Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record 6. Able and willing to complete post-vaccine assessments and questionnaires independently or with assistance 7. Able and willing to have blood drawn for the study 8. Able and willing to return in about one month for a follow-up visit including completing questionnaires and having another blood test 9. Access to and ability to use a phone, independently or with assistance 10. Adequate vision and motor skills to complete the diary form independently or with assistance. 11. Not living in a skilled nursing facility/nursing home/long term acute care facility
Exclusion criteria
1. IIV receipt during the current influenza season prior to study enrollment 2. Enrolled in this study during the 2017-18 (Year 1) influenza season Note: Year 1 study participants will only be enrolled in Year 2 if they are participating in the sub-study on repeat vaccination 3. Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 12 months. 4. Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy\* \*Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 12 months) 5. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection 6. History of febrile illness (\> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration (temporary deferral) 7. Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component\*, including egg protein; or a latex allergy \*Formaldehyde, Octylphenol ethoxylate, neomycin, kanamycin, barium, cetyltrimethlyammonium bromide (CTAB) 8. Any history of Guillain-Barré syndrome 9. Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal Dementia Assessment Scale (RUDAS) 10. Substance use that could interfere with study compliance 11. Receipt of any inactivated licensed vaccine within 2 weeks, or live attenuated licensed vaccine within 4 weeks prior to enrollment in this study, or planning receipt of any vaccines during the 42-days post-vaccination period (including pneumococcal vaccines) 12. Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 30 days following vaccine receipt. 13. Hearing loss determined by the investigators to prevent successful communication over the phone 14. Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives. 15. Anyone who is a relative or subordinate of any research study personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | Days 1 through 8 post-vaccination | Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups. |
| Number of Participants With Adverse Events of Clinical Interest, Population 2 | 42 days post-vaccination and compared between the two groups. | The frequency and descriptions of adverse events of clinical interest observed in the two treatment groups. |
| Observed Serious Adverse Events in Both Treatment Groups, Population 2 | 42 days post-vaccination and compared between the two groups. | The frequency and descriptions of serious adverse events observed in the two treatment groups. No analytical analysis was completed. |
| Number of Participants With H3N2 HAI Seroconversion | 29 days post-vaccination | H3N2 hemagglutination inhibition assay (HAI) seroconversion: The proportion of subjects achieving H3N2 seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer is \> 1:10) in the respective season's vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Days 1 through 8 post-vaccination | Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group. |
| Number of Participants With System Reactions - Ages 80 +, Population 1 | Days 1 through 8 post-vaccination | Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group. |
| Quality of Life - Late Life Function & Disability Instrument - Full Population | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1). |
| Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1). |
| Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1). |
| Quality of Life - EQ-5D-5L -Full Population | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health). |
| Quality of Life - EQ-5D-5L - Ages 65 - 79 | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health). |
| Quality of Life - EQ-5D-5L - Ages 80 + | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only) Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health). |
| Quality of Life - EQ VAS -Full Population | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). |
| Quality of Life - EQ VAS - Ages 65 - 79 | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). |
| Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Days 1 through 8 post-vaccination | Comparison of local reactions within the first week post-vaccination in both treatment groups. |
| Seroconversion - 65 and Older | Day 29 (28 days post-vaccination) | The proportion of subjects achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer |
| Seroprotection - 65 and Older | Day 29 (28 days post-vaccination) | Proportion of subjects with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine |
| Geometric Mean HAI Titer - 65 and Older | Day 29 (28 days post-vaccination) | The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine |
| Seroconversion - Ages 65-79 | Day 29 (28 days post-vaccination) | The proportion of subjects aged 65-79 achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer |
| Seroconversion - Ages 80 and Older | Day 29 (28 days post-vaccination) | The proportion of subjects ages 80 and older achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer |
| Seroprotection - Ages 65-79 | Day 29 (28 days post-vaccination) | Proportion of subjects ages 65-79 with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine |
| Seroprotection - Ages 80 and Older | Day 29 (28 days post-vaccination) | Proportion of subjects ages 80 and older with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine |
| Geometric Mean HAI Titer - Ages 65-79 | Day 29 (28 days post-vaccination) | The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 65-79 |
| Geometric Mean HAI Titer - Ages 80 and Older | Day 29 (28 days post-vaccination) | The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 80 and older |
| Quality of Life - EQ VAS - Ages 80 + | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) | Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). |
| Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Days 1 through 8 post-vaccination | Comparison of local reactions within the first week post-vaccination in both treatment groups by age group. |
| Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Days 1 through 8 post-vaccination | Comparison of local reactions within the first week post-vaccination in both treatment groups by age group. |
| Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Days 1 through 8 post-vaccination | Comparison of systemic reactions within the first week post-vaccination in both treatment groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adjuvanted Influenza Vaccine (FLUAD) In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine | 378 |
| High-dose Influenza Vaccine (Fluzone HD) In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine | 379 |
| Total | 757 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing Symptom Diary Data | 0 | 2 |
Baseline characteristics
| Characteristic | Adjuvanted Influenza Vaccine (FLUAD) | High-dose Influenza Vaccine (Fluzone HD) | Total |
|---|---|---|---|
| Age, Customized Age Group 65-79 Years | 298 Participants | 296 Participants | 594 Participants |
| Age, Customized Age Group 80 or More | 80 Participants | 83 Participants | 163 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 346 Participants | 351 Participants | 697 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 27 Participants | 52 Participants |
| Race/Ethnicity, Customized Race Black only | 70 Participants | 59 Participants | 129 Participants |
| Race/Ethnicity, Customized Race Other | 22 Participants | 17 Participants | 39 Participants |
| Race/Ethnicity, Customized Race White Only | 286 Participants | 303 Participants | 589 Participants |
| Region of Enrollment United States | 378 participants | 379 participants | 757 participants |
| Sex: Female, Male Female | 213 Participants | 207 Participants | 420 Participants |
| Sex: Female, Male Male | 165 Participants | 172 Participants | 337 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 378 | 1 / 379 |
| other Total, other adverse events | 15 / 378 | 19 / 379 |
| serious Total, serious adverse events | 10 / 378 | 4 / 379 |
Outcome results
Primary
Number of Participants With Adverse Events of Clinical Interest, Population 2
The frequency and descriptions of adverse events of clinical interest observed in the two treatment groups.
Time frame: 42 days post-vaccination and compared between the two groups.
Population: Full Analysis Population 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Adverse Events of Clinical Interest, Population 2 | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Adverse Events of Clinical Interest, Population 2 | 0 Participants |
Primary
Number of Participants With H3N2 HAI Seroconversion
H3N2 hemagglutination inhibition assay (HAI) seroconversion: The proportion of subjects achieving H3N2 seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer is \> 1:10) in the respective season's vaccine
Time frame: 29 days post-vaccination
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With H3N2 HAI Seroconversion | 112 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With H3N2 HAI Seroconversion | 130 Participants |
p-value: 0.1245Cochran-Mantel-Haenszel
Primary
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups.
Time frame: Days 1 through 8 post-vaccination
Population: Full Analysis Population 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | None | 297 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | Mild | 69 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | Mod/Severe | 12 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | None | 282 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | Mild | 73 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 | Mod/Severe | 22 Participants |
Comparison: The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.95% CI: [-5.8, 0.4]
Primary
Observed Serious Adverse Events in Both Treatment Groups, Population 2
The frequency and descriptions of serious adverse events observed in the two treatment groups. No analytical analysis was completed.
Time frame: 42 days post-vaccination and compared between the two groups.
Population: Full Analysis Population 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Post-operative ileus | 0 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Asthma exacerbation | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Stress induced cardiomyopathy | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Near syncope due to orthostasis | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Metastatic squamous cell | 0 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Pulmonary emboli | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | TIA | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Small bowel obstruction | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Respiratory Failure | 1 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | SAEs related to study product | 0 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Chest Pain | 0 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | SAEs not related to study product | 9 SAE Events |
| Adjuvanted Influenza Vaccine (FLUAD®) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Fall | 2 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | SAEs not related to study product | 3 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Fall | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Metastatic squamous cell | 1 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Post-operative ileus | 1 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Respiratory Failure | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Stress induced cardiomyopathy | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | TIA | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Chest Pain | 1 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Asthma exacerbation | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Near syncope due to orthostasis | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Pulmonary emboli | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | Small bowel obstruction | 0 SAE Events |
| High-dose Influenza Vaccine (Fluzone® HD) | Observed Serious Adverse Events in Both Treatment Groups, Population 2 | SAEs related to study product | 0 SAE Events |
95% CI: [1.09, 4.47]
95% CI: [0.16, 2.23]
Secondary
Geometric Mean HAI Titer - 65 and Older
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | A/H1N1 - Baseline | 51.8 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | A/H1N1 - Post-vaccination | 100.0 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | A/H3N2 - Baseline | 63.4 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | A/H3N2 - Post-vaccination | 141.7 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | Influenza B - Baseline | 13.4 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - 65 and Older | Influenza B - Post-vaccination | 21.6 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | Influenza B - Baseline | 14.7 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | A/H1N1 - Baseline | 50.8 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | A/H3N2 - Post-vaccination | 177.3 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | A/H1N1 - Post-vaccination | 98.0 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | Influenza B - Post-vaccination | 27.5 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - 65 and Older | A/H3N2 - Baseline | 58.5 GMT |
Secondary
Geometric Mean HAI Titer - Ages 65-79
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 65-79
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | A/H1N1 - Baseline | 52.5 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | A/H1N1 - Post-vaccination | 108.8 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | A/H3N2 - Baseline | 63.3 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | A/H3N2 - Post-vaccination | 145.3 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | Influenza B - Baseline | 12.2 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 65-79 | Influenza B - Post-vaccination | 20.3 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | Influenza B - Baseline | 11.8 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | A/H1N1 - Baseline | 49.5 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | A/H3N2 - Post-vaccination | 184.4 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | A/H1N1 - Post-vaccination | 100.9 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | Influenza B - Post-vaccination | 23.8 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 65-79 | A/H3N2 - Baseline | 56.4 GMT |
Secondary
Geometric Mean HAI Titer - Ages 80 and Older
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 80 and older
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | A/H1N1 - Baseline | 49.3 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | A/H1N1 - Post-vaccination | 73.4 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | A/H3N2 - Baseline | 63.7 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | A/H3N2 - Post-vaccination | 129.2 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | Influenza B - Baseline | 18.7 GMT |
| Adjuvanted Influenza Vaccine (FLUAD®) | Geometric Mean HAI Titer - Ages 80 and Older | Influenza B - Post-vaccination | 27.0 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | Influenza B - Baseline | 31.2 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | A/H1N1 - Baseline | 55.6 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | A/H3N2 - Post-vaccination | 155.0 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | A/H1N1 - Post-vaccination | 88.7 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | Influenza B - Post-vaccination | 45.0 GMT |
| High-dose Influenza Vaccine (Fluzone® HD) | Geometric Mean HAI Titer - Ages 80 and Older | A/H3N2 - Baseline | 66.5 GMT |
Secondary
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Time frame: Days 1 through 8 post-vaccination
Population: Participants 65-79 years of age in Full Analysis Population 1
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | Mild | 36 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | Mod/Severe | 6 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | Mild | 21 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | None | 157 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | Mod/Severe | 16 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | Mild | 117 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | None | 246 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | Mod/Severe | 24 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | None | 264 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | None | 232 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | Mild | 56 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | Mild | 28 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | Mod/Severe | 10 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | None | 274 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | Mod/Severe | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | None | 267 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | Mild | 17 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Redness | Mod/Severe | 10 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | None | 249 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | Mild | 33 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Shoulder Pain | Mod/Severe | 12 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | None | 253 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | Mild | 22 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Swelling | Mod/Severe | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | None | 138 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | Mild | 137 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Tenderness | Mod/Severe | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | None | 210 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 | Injection Site Pain | Mild | 65 Participants |
Comparison: Redness95% CI: [-5.2, 0.2]
Comparison: Shoulder Pain95% CI: [-2.3, 4.9]
Comparison: Swelling95% CI: [-8.1, -1.1]
Comparison: Tenderness95% CI: [-2.7, 5.9]
Comparison: Injection Site Pain95% CI: [-6.9, 0.4]
Secondary
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Time frame: Days 1 through 8 post-vaccination
Population: Participants 80+ years of age in Full Analysis Population 1
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | Mild | 8 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | Mild | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | None | 44 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | Mod/Severe | 1 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | Mild | 33 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | None | 71 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | None | 71 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | None | 65 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | Mild | 13 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | Mild | 6 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | None | 74 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | None | 74 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | Mild | 6 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Redness | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | None | 77 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | Mild | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Shoulder Pain | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | None | 75 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | Mild | 4 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Swelling | Mod/Severe | 4 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | None | 58 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | Mild | 23 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Tenderness | Mod/Severe | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | None | 72 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1 | Injection Site Pain | Mild | 8 Participants |
Comparison: Redness95% CI: [-7.3, 7.3]
Comparison: Shoulder Pain95% CI: [-9.5, 5.7]
Comparison: Swelling95% CI: [-8.6, 6.1]
Comparison: Tenderness95% CI: [-5.7, 8.3]
Comparison: Injection Site Pain95% CI: [-7.9, 5.4]
Secondary
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups.
Time frame: Days 1 through 8 post-vaccination
Population: Full Analysis Population 1
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | None | 348 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | Mild | 24 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | Mod/Severe | 6 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | None | 317 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | Mild | 44 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | Mod/Severe | 17 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | None | 335 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | Mild | 34 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | Mod/Severe | 9 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | None | 201 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | Mild | 150 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | Mod/Severe | 27 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | Mild | 160 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | None | 341 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | None | 23 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | Mild | 23 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | None | 196 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Redness | Mod/Severe | 13 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | Mild | 26 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | None | 326 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Tenderness | Mod/Severe | 21 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | Mild | 36 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Swelling | Mod/Severe | 328 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1 | Shoulder Pain | Mod/Severe | 15 Participants |
Comparison: Redness98% CI: [-5, 1]
Comparison: Shoulder Pain98% CI: [-3.1, 4.3]
Comparison: Swelling98% CI: [-7.5, -0.3]
Comparison: Tenderness98% CI: [-2.7, 5.9]
Secondary
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Comparison of systemic reactions within the first week post-vaccination in both treatment groups.
Time frame: Days 1 through 8 post-vaccination
Population: Full Analysis Population 1:~Four missing patient-reported outcome measures for Fever outcome.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | None | 335 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | Mod/Severe | 5 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | Mild | 36 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | Mild | 20 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | Mod/Severe | 7 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | None | 319 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | None | 332 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | Mild | 28 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | Mild | 32 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | Mod/Severe | 18 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | None | 362 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | None | 334 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | Mod/Severe | 27 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | Mild | 25 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | None | 358 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | Mod/Severe | 19 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | None | 366 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | None | 357 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | Mod/Severe | 18 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | Mild | 19 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | Mild | 11 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | Mild | 15 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | None | 374 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | Mod/Severe | 1 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | Mild | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | Mild | 13 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | None | 340 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | Mod/Severe | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | None | 346 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | Mild | 20 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Arthralgia | Mod/Severe | 11 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | None | 363 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | Mild | 9 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Chills/Shivering | Mod/Severe | 5 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | None | 359 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | Mild | 9 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Diarrhea | Mod/Severe | 9 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | None | 337 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | Mild | 25 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fatigue | Mod/Severe | 15 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | None | 358 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | Mild | 12 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Fever | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | None | 338 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | Mild | 31 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Headache | Mod/Severe | 8 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | None | 344 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | Mild | 22 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Malaise | Mod/Severe | 11 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | None | 338 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | Mild | 22 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Myalgia | Mod/Severe | 17 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | None | 362 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | Mild | 10 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Nausea | Mod/Severe | 5 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | None | 374 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With Systemic Reactions - Full Study Population, Population 1 | Vomiting | Mild | 1 Participants |
Comparison: Arthralgia98% CI: [-1.7, 5.4]
Comparison: Chills/Shivering98% CI: [-2.8, 2.3]
Comparison: Diarrhea98% CI: [-4, 1.5]
Comparison: Fatigue98% CI: [-0.8, 7.3]
Comparison: Fever98% CI: [-2.5, 2]
Comparison: Headache98% CI: [-3, 2.4]
Comparison: Malaise98% CI: [-1.7, 5.4]
Comparison: Myalgia98% CI: [-3.3, 4.4]
Comparison: Nausea98% CI: [-3.1, 1.6]
Comparison: Vomiting98% CI: [-1.8, 1.8]
Secondary
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Time frame: Days 1 through 8 post-vaccination
Population: Participants 65-79 years of age in Full Analysis Population 1: Three missing Fever outcome values for the Fluzone HD group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | None | 259 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | Mod/Severe | 5 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | Mild | 32 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | Mild | 16 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | Mod/Severe | 7 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | None | 248 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | None | 260 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | Mild | 24 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | Mild | 27 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | Mod/Severe | 14 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | None | 283 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | None | 262 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | Mod/Severe | 23 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | Mild | 20 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | None | 280 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | Mod/Severe | 16 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | None | 288 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | None | 280 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | Mod/Severe | 16 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | Mild | 16 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | Mild | 10 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | Mild | 13 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | None | 294 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | Mild | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | Mild | 12 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | None | 266 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | Mod/Severe | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | None | 266 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | Mild | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Arthralgia | Mod/Severe | 9 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | None | 282 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | Mild | 7 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Chills/Shivering | Mod/Severe | 5 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | None | 280 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | Mild | 7 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Diarrhea | Mod/Severe | 7 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | None | 258 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | Mild | 22 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fatigue | Mod/Severe | 14 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | None | 278 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | Mild | 10 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Fever | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | None | 257 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | Mild | 29 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Headache | Mod/Severe | 8 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | None | 264 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | Mild | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Malaise | Mod/Severe | 11 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | None | 261 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | Mild | 19 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Myalgia | Mod/Severe | 14 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | None | 280 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | Mild | 9 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Nausea | Mod/Severe | 5 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | None | 291 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 65 - 79, Population 1 | Vomiting | Mild | 1 Participants |
Comparison: Arthralgia95% CI: [-1.1, 5.8]
Comparison: Chills/Shivering95% CI: [-3, 2]
Comparison: Diarrhea95% CI: [-3.5, 1.8]
Comparison: Fatigue95% CI: [-1.1, 7]
Comparison: Fever95% CI: [-3, -0.4]
Comparison: Headache95% CI: [-3.2, 2.4]
Comparison: Malaise95% CI: [-2.5, 4.5]
Comparison: Myalgia95% CI: [-3.1, 4.3]
Comparison: Nausea95% CI: [-3.3, 1.3]
Comparison: Vomiting95% CI: [-1.8, 1.8]
Secondary
Number of Participants With System Reactions - Ages 80 +, Population 1
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Time frame: Days 1 through 8 post-vaccination
Population: Participants 80+ years of age in Full Analysis Population 1: One missing Fever outcome value in the Fluzone HD group.~No statistical analysis completed on following Outcomes: Chills/Shivering, Headache, Nausea, Vomiting because none reported in this age group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | Mod/Severe | 1 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | Mild | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | None | 76 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | None | 74 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | Mild | 4 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | Mild | 1 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | None | 72 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | None | 71 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | Mild | 4 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | Mod/Severe | 2 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | Mod/Severe | 4 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | Mild | 5 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | None | 72 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | Mild | 5 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | Mod/Severe | 4 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | Mod/Severe | 3 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | Mild | 4 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | None | 77 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | None | 78 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | None | 78 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | None | 80 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | Mild | 1 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | Mild | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | None | 79 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | Mod/Severe | 0 Participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | Mild | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | Mild | 1 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | None | 80 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | Mild | 1 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Arthralgia | Mod/Severe | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | None | 81 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | Mild | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Chills/Shivering | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | None | 79 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | Mild | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Diarrhea | Mod/Severe | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | None | 79 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | Mild | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fatigue | Mod/Severe | 1 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | None | 80 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | Mild | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Fever | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | None | 81 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | Mild | 2 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Headache | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | None | 80 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | Mild | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Malaise | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | None | 77 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | Mild | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Myalgia | Mod/Severe | 3 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | None | 82 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Nausea | Mod/Severe | 0 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | None | 83 Participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Number of Participants With System Reactions - Ages 80 +, Population 1 | Vomiting | Mild | 0 Participants |
Comparison: Arthralgia95% CI: [-7.2, 6.4]
Comparison: Diarrhea95% CI: [-8.1, -0.6]
Comparison: Fatigue95% CI: [-3.6, 10.9]
Comparison: Fever95% CI: [-2.4, 6.6]
Comparison: Malaise95% CI: [2, 12.2]
Comparison: Myalgia95% CI: [-7.3, 7.3]
Secondary
Quality of Life - EQ-5D-5L - Ages 65 - 79
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 65-79 years of age. EQ-5D-5L data collected for only one year.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ-5D-5L - Ages 65 - 79 | -0.054 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ-5D-5L - Ages 65 - 79 | -0.051 Change in score |
Comparison: US Index Score Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.4032Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - EQ-5D-5L - Ages 80 +
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only) Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 80+ years of age. EQ-5D-5L data collected for only one year.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ-5D-5L - Ages 80 + | -0.055 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ-5D-5L - Ages 80 + | -0.062 Change in score |
Comparison: US Index Score Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.4079Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - EQ-5D-5L -Full Population
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: EQ-5D-5L data collected for only one year.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ-5D-5L -Full Population | -0.054 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ-5D-5L -Full Population | -0.053 Change in score |
Comparison: US Index Score Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.7407Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - EQ VAS - Ages 65 - 79
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 65-79 years of age.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ VAS - Ages 65 - 79 | -2.474 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ VAS - Ages 65 - 79 | -2.791 Change in score |
Comparison: EQ VAS Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.7953Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - EQ VAS - Ages 80 +
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 80+ years of age.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ VAS - Ages 80 + | -1.295 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ VAS - Ages 80 + | -1.463 Change in score |
Comparison: EQ VAS Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.9329Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - EQ VAS -Full Population
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: EQ VAS data collected for only one year.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - EQ VAS -Full Population | -2.222 Change in score |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - EQ VAS -Full Population | -2.496 Change in score |
Comparison: EQ VAS Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.7948Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 65-79 years of age. LLFDI data collected for only one year.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Activity Limitation | -1.35 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Daily Activities | -1.16 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Basic Mobility | -1.33 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Participation Restriction | -0.81 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Social Roles | -0.66 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Instrumental Roles | -1.00 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Social Roles | -1.98 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Activity Limitation | -2.12 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Participation Restriction | -1.69 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Daily Activities | -1.88 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Instrumental Roles | -1.70 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79 | Basic Mobility | -2.29 score on a scale |
Comparison: Activity Limitation Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.6278Wilcoxon (Mann-Whitney)
Comparison: Daily Activities Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.5622Wilcoxon (Mann-Whitney)
Comparison: Basic Mobility Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.5538Wilcoxon (Mann-Whitney)
Comparison: Participation Restriction Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.231Wilcoxon (Mann-Whitney)
Comparison: Social Roles Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.0435Wilcoxon (Mann-Whitney)
Comparison: Instrumental Roles Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.6519Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: Participants 80+ years of age. LLFDI data collected for only one year.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Activity Limitation | -1.94 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Daily Activities | -1.86 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Basic Mobility | -1.62 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Participation Restriction | -1.17 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Social Roles | -1.45 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Instrumental Roles | -1.54 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Social Roles | -0.72 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Activity Limitation | -2.99 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Participation Restriction | -0.97 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Daily Activities | -3.13 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Instrumental Roles | -1.44 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Ages 80 + | Basic Mobility | -3.23 score on a scale |
Comparison: Activity Limitation Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.7483Wilcoxon (Mann-Whitney)
Comparison: Daily Activities Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.7483Wilcoxon (Mann-Whitney)
Comparison: Basic Mobility Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.4953Wilcoxon (Mann-Whitney)
Comparison: Participation Restriction Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.8669Wilcoxon (Mann-Whitney)
Comparison: Social Roles Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.8451Wilcoxon (Mann-Whitney)
Comparison: Instrumental Roles Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.7376Wilcoxon (Mann-Whitney)
Secondary
Quality of Life - Late Life Function & Disability Instrument - Full Population
Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Population: LLFDI data collected for only one year.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Activity Limitation | -1.43 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Daily Activities | -1.26 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Basic Mobility | -1.37 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Participation Restriction | -0.86 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Social Roles | -0.77 score on a scale |
| Adjuvanted Influenza Vaccine (FLUAD®) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Instrumental Roles | -1.08 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Social Roles | -1.80 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Activity Limitation | -2.25 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Participation Restriction | -1.58 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Daily Activities | -2.06 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Instrumental Roles | -1.66 score on a scale |
| High-dose Influenza Vaccine (Fluzone® HD) | Quality of Life - Late Life Function & Disability Instrument - Full Population | Basic Mobility | -2.43 score on a scale |
Comparison: Activity Limitation Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.5862Wilcoxon (Mann-Whitney)
Comparison: Daily Activities Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.5648Wilcoxon (Mann-Whitney)
Comparison: Basic Mobility Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.4196Wilcoxon (Mann-Whitney)
Comparison: Participation Restriction Changes from Day 1 to Day 3 Group Comparisonsp-value: 0.2418Wilcoxon (Mann-Whitney)
Comparison: Social Roles Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.0746Wilcoxon (Mann-Whitney)
Comparison: Instrumental Roles Changes for Day 1 to Day 3 Group Comparisonsp-value: 0.5497Wilcoxon (Mann-Whitney)
Secondary
Seroconversion - 65 and Older
The proportion of subjects achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - 65 and Older | A/H1N1 | 28.1 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - 65 and Older | Influenza B | 18.7 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - 65 and Older | A/H1N1 | 26.6 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - 65 and Older | Influenza B | 23.4 percentage of participants |
Secondary
Seroconversion - Ages 65-79
The proportion of subjects aged 65-79 achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 65-79 | A/H1N1 | 29.7 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 65-79 | A/H3N2 | 34.2 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 65-79 | Influenza B | 19.0 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 65-79 | A/H1N1 | 27.2 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 65-79 | A/H3N2 | 39.5 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 65-79 | Influenza B | 26.1 percentage of participants |
Secondary
Seroconversion - Ages 80 and Older
The proportion of subjects ages 80 and older achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 80 and Older | A/H1N1 | 21.9 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 80 and Older | A/H3N2 | 27.4 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroconversion - Ages 80 and Older | Influenza B | 17.8 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 80 and Older | A/H1N1 | 24.7 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 80 and Older | A/H3N2 | 35.1 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroconversion - Ages 80 and Older | Influenza B | 14.3 percentage of participants |
Secondary
Seroprotection - 65 and Older
Proportion of subjects with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | A/H1N1 - Baseline | 69.6 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | A/H1N1 - Post-vaccination | 83.3 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | A/H3N2 - Baseline | 66.7 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | A/H3N2 - Post-vaccination | 89.8 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | Influenza B - Baseline | 24.6 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - 65 and Older | Influenza B - Post-vaccination | 44.2 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | Influenza B - Baseline | 26.9 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | A/H1N1 - Baseline | 66.9 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | A/H3N2 - Post-vaccination | 88.5 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | A/H1N1 - Post-vaccination | 83.4 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | Influenza B - Post-vaccination | 48.8 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - 65 and Older | A/H3N2 - Baseline | 65.7 percentage of participants |
Secondary
Seroprotection - Ages 65-79
Proportion of subjects ages 65-79 with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | A/H1N1 - Baseline | 69.9 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | A/H1N1 - Post-vaccination | 83.6 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | A/H3N2 - Baseline | 67.3 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | A/H3N2 - Post-vaccination | 91.4 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | Influenza B - Baseline | 22.3 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 65-79 | Influenza B - Post-vaccination | 42.4 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | Influenza B - Baseline | 19.9 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | A/H1N1 - Baseline | 65.5 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | A/H3N2 - Post-vaccination | 88.1 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | A/H1N1 - Post-vaccination | 82.8 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | Influenza B - Post-vaccination | 45.2 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 65-79 | A/H3N2 - Baseline | 65.5 percentage of participants |
Secondary
Seroprotection - Ages 80 and Older
Proportion of subjects ages 80 and older with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Time frame: Day 29 (28 days post-vaccination)
Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | A/H1N1 - Baseline | 68.5 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | A/H1N1 - Post-vaccination | 82.2 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | A/H3N2 - Baseline | 64.4 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | A/H3N2 - Post-vaccination | 83.6 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | Influenza B - Baseline | 32.9 percentage of participants |
| Adjuvanted Influenza Vaccine (FLUAD®) | Seroprotection - Ages 80 and Older | Influenza B - Post-vaccination | 50.7 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | Influenza B - Baseline | 50.6 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | A/H1N1 - Baseline | 71.4 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | A/H3N2 - Post-vaccination | 89.6 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | A/H1N1 - Post-vaccination | 85.7 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | Influenza B - Post-vaccination | 61.0 percentage of participants |
| High-dose Influenza Vaccine (Fluzone® HD) | Seroprotection - Ages 80 and Older | A/H3N2 - Baseline | 66.2 percentage of participants |