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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Boston Medical Center | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvanted influenza vaccine (FLUAD®) | Active Comparator | In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1. |
|
| High-dose influenza vaccine (Fluzone® HD) | Active Comparator | In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLUAD® | Biological | Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1 through 8 post-vaccination |
| 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. | 42 days post-vaccination and compared between the two groups. |
| 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. | 42 days post-vaccination and compared between the two groups. |
| 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 | 29 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1 through 8 post-vaccination |
| Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1 |
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Inclusion Criteria:
Exclusion Criteria:
IIV receipt during the current influenza season prior to study enrollment
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
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.
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)
Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection
History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration (temporary deferral)
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)
Any history of Guillain-Barré syndrome
Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal Dementia Assessment Scale (RUDAS)
Substance use that could interfere with study compliance
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)
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.
Hearing loss determined by the investigators to prevent successful communication over the phone
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.
Anyone who is a relative or subordinate of any research study personnel.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Schmader, MD | Duke University | Principal Investigator |
| Theresa Harrington, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Elizabeth Barnett, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37393237 | Derived | Schmader KE, Liu CK, Flannery B, Rountree W, Auerbach H, Barnett ED, Schlaudecker EP, Todd CA, Poniewierski M, Staat MA, Harrington T, Li R, Broder KR, Walter EB. Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial. Immun Ageing. 2023 Jul 1;20(1):30. doi: 10.1186/s12979-023-00355-7. | |
| 33443580 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine, Adjuvanted (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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The primary analysis population will be the Full Analysis Population 2; defined as all subjects who are randomized and vaccinated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | High-dose Influenza Vaccine (Fluzone HD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Population 1 | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
|
Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred >42 days post vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Cold symptoms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Schmader | Duke University | 919-660-7572 | kenneth.schmader@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2018 | Feb 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000075662 | Injection Site Reaction |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005119 | Extravasation of Diagnostic and Therapeutic Materials |
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| ID | Term |
|---|---|
| C478243 | fluad vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Subject, study coordinators, and investigators will be blinded to the type of flu vaccine administered. Only the vaccinator will be unblinded.
| Fluzone® High-Dose | Biological | Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
|
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group. |
| Days 1 through 8 post-vaccination |
| 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. | Days 1 through 8 post-vaccination |
| 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. | Days 1 through 8 post-vaccination |
| 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. | Days 1 through 8 post-vaccination |
| 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. | Days 1 through 8 post-vaccination |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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). | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| Geometric Mean HAI Titer - 65 and Older | The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| 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 | Day 29 (28 days post-vaccination) |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Schmader KE, Liu CK, Harrington T, Rountree W, Auerbach H, Walter EB, Barnett ED, Schlaudecker EP, Todd CA, Poniewierski M, Staat MA, Wodi P, Broder KR. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2031266. doi: 10.1001/jamanetworkopen.2020.31266. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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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
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| 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. | Full Analysis Population 2 | Posted | Count of Participants | Participants | 42 days post-vaccination and compared between the two groups. |
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| 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. | Full Analysis Population 2 | Posted | Number | SAE Events | 42 days post-vaccination and compared between the two groups. |
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| 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 | 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. | Posted | Count of Participants | Participants | 29 days post-vaccination |
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| 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. | Full Analysis Population 1 | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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. | Participants 65-79 years of age in Full Analysis Population 1 | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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. | Participants 80+ years of age in Full Analysis Population 1 | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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. | Full Analysis Population 1: Four missing patient-reported outcome measures for "Fever" outcome. | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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. | Participants 65-79 years of age in Full Analysis Population 1: Three missing "Fever" outcome values for the Fluzone HD group. | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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. | 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. | Posted | Count of Participants | Participants | Days 1 through 8 post-vaccination |
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| 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). | LLFDI data collected for only one year. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
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| 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). | Participants 65-79 years of age. LLFDI data collected for only one year. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
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| 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). | Participants 80+ years of age. LLFDI data collected for only one year. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
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| 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). | EQ-5D-5L data collected for only one year. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
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|
|
| 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). | Participants 65-79 years of age. EQ-5D-5L data collected for only one year. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
|
|
|
|
| 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). | Participants 80+ years of age. EQ-5D-5L data collected for only one year. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
|
|
|
|
| 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). | EQ VAS data collected for only one year. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
|
|
|
|
| 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). | Participants 65-79 years of age. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
|
|
|
|
| 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). | Participants 80+ years of age. | Posted | Mean | 95% Confidence Interval | Change in score | Pre-vaccination (Day 1), 2 days post-vaccination (Day 3) |
|
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| Secondary | Geometric Mean HAI Titer - 65 and Older | The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine | 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. | Posted | Number | 95% Confidence Interval | GMT | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | GMT | Day 29 (28 days post-vaccination) |
|
|
|
| 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 | 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. | Posted | Number | 95% Confidence Interval | GMT | Day 29 (28 days post-vaccination) |
|
|
|
| 1 |
| 378 |
| 10 |
| 378 |
| 15 |
| 378 |
| EG001 | 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 | 1 | 379 | 4 | 379 | 19 | 379 |
| Fall | General disorders | Non-systematic Assessment |
|
| Metastatic squamous cell | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Post-operative ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Stressed induced cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| TIA | Nervous system disorders | Non-systematic Assessment |
|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Near syncope due to orthostatic | Nervous system disorders | Non-systematic Assessment |
|
| Pulmonary emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
|
Not provided
Not provided
| D010335 | Pathologic Processes |
| D064419 | Chemically-Induced Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Post-operative ileus |
|
| Respiratory Failure |
|
| Stress induced cardiomyopathy |
|
| TIA |
|
| Chest Pain |
|
| Asthma exacerbation |
|
| Near syncope due to orthostasis |
|
| Pulmonary emboli |
|
| Small bowel obstruction |
|
| SAEs related to study product |
|
| SAEs not related to study product |
|
| Comparison of Frequencies |
| .79 |
| 2-Sided |
| 95 |
| 0.16 |
| 2.23 |
| Other |
The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals. |
| Mod/Severe |
|
| Shoulder Pain |
|
| Swelling |
|
| Tenderness |
|
|
Shoulder Pain |
| Difference in proportions |
| 0.5 |
| 2-Sided |
| 98 |
| -3.1 |
| 4.3 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Swelling | Difference in proportions | -3.7 | 2-Sided | 98 | -7.5 | -0.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Tenderness | Difference in proportions | 1.6 | 2-Sided | 98 | -2.7 | 5.9 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Mod/Severe |
|
| Shoulder Pain |
|
| Swelling |
|
| Tenderness |
|
| Injection Site Pain |
|
Shoulder Pain |
| Difference in proportions |
| 1.3 |
| 2-Sided |
| 95 |
| -2.3 |
| 4.9 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Swelling | Difference in proportions | -4.5 | 2-Sided | 95 | -8.1 | -1.1 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Tenderness | Difference in proportions | 1.6 | 2-Sided | 95 | -2.7 | 5.9 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Injection Site Pain | Difference in proportions | -3.1 | 2-Sided | 95 | -6.9 | 0.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Mod/Severe |
|
| Shoulder Pain |
|
| Swelling |
|
| Tenderness |
|
| Injection Site Pain |
|
Shoulder Pain |
| Difference in proportions |
| -2.3 |
| 2-Sided |
| 95 |
| -9.5 |
| 5.7 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Swelling | Difference in proportions | -1.2 | 2-Sided | 95 | -8.6 | 6.1 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Tenderness | Difference in proportions | 1.4 | 2-Sided | 95 | -5.7 | 8.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Injection Site Pain | Difference in proportions | -1.2 | 2-Sided | 95 | -7.9 | 5.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Mild |
|
| Mod/Severe |
|
| Chills/Shivering |
|
|
| Diarrhea |
|
|
| Fatigue |
|
|
| Fever |
|
|
| Headache |
|
|
| Malaise |
|
|
| Myalgia |
|
|
| Nausea |
|
|
| Vomiting |
|
|
|
Chills/Shivering |
| Difference in proportions |
| -0.5 |
| 2-Sided |
| 98 |
| -2.8 |
| 2.3 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Diarrhea | Difference in proportions | -1.1 | 2-Sided | 98 | -4.0 | 1.5 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Fatigue | Difference in proportions | 3.2 | 2-Sided | 98 | -0.8 | 7.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Fever | Difference in proportions | 0.5 | 2-Sided | 98 | -2.5 | 2.0 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Headache | Difference in proportions | -0.3 | 2-Sided | 98 | -3.0 | 2.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Malaise | Difference in proportions | 1.8 | 2-Sided | 98 | -1.7 | 5.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Myalgia | Difference in proportions | 0.5 | 2-Sided | 98 | -3.3 | 4.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Nausea | Difference in proportions | -0.8 | 2-Sided | 98 | -3.1 | 1.6 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Vomiting | Difference in proportions | -0.0 | 2-Sided | 98 | -1.8 | 1.8 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons. |
| Mild |
|
| Mod/Severe |
|
| Chills/Shivering |
|
|
| Diarrhea |
|
|
| Fatigue |
|
|
| Fever |
|
|
| Headache |
|
|
| Malaise |
|
|
| Myalgia |
|
|
| Nausea |
|
|
| Vomiting |
|
|
Chills/Shivering |
| Difference in proportions |
| -0.7 |
| 2-Sided |
| 95 |
| -3.0 |
| 2.0 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Diarrhea | Difference in proportions | -0.7 | 2-Sided | 95 | -3.5 | 1.8 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Fatigue | Difference in proportions | 2.9 | 2-Sided | 95 | -1.1 | 7.0 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Fever | Difference in proportions | -1.0 | 2-Sided | 95 | -3.0 | -0.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Headache | Difference in proportions | -0.4 | 2-Sided | 95 | -3.2 | 2.4 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Malaise | Difference in proportions | 0.9 | 2-Sided | 95 | -2.5 | 4.5 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Myalgia | Difference in proportions | 0.6 | 2-Sided | 95 | -3.1 | 4.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Nausea | Difference in proportions | -1.0 | 2-Sided | 95 | -3.3 | 1.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Vomiting | Difference in proportions | -0.0 | 2-Sided | 95 | -1.8 | 1.8 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Mild |
|
| Mod/Severe |
|
| Chills/Shivering |
|
|
| Diarrhea |
|
|
| Fatigue |
|
|
| Fever |
|
|
| Headache |
|
|
| Malaise |
|
|
| Myalgia |
|
|
| Nausea |
|
|
| Vomiting |
|
|
Diarrhea |
| Difference in proportions |
| -2.4 |
| 2-Sided |
| 95 |
| -8.1 |
| -0.6 |
The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. |
| Non-Inferiority |
Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Fatigue | Difference in proportions | 3.7 | 2-Sided | 95 | -3.6 | 10.9 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Fever | Difference in proportions | 1.2 | 2-Sided | 95 | -2.4 | 6.6 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Malaise | Difference in proportions | 5.0 | 2-Sided | 95 | 2.0 | 12.2 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Myalgia | Difference in proportions | 0.1 | 2-Sided | 95 | -7.3 | 7.3 | The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used. | Non-Inferiority | Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level. |
| Basic Mobility |
|
| Participation Restriction |
|
| Social Roles |
|
| Instrumental Roles |
|
Daily Activities Changes for Day 1 to Day 3 Group Comparisons |
| Wilcoxon (Mann-Whitney) |
| 0.5648 |
| Superiority |
Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons. |
| Basic Mobility Changes from Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.4196 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons. |
| Participation Restriction Changes from Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.2418 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons. |
| Social Roles Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.0746 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons. |
| Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.5497 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons. |
| Basic Mobility |
|
| Participation Restriction |
|
| Social Roles |
|
| Instrumental Roles |
|
Daily Activities Changes for Day 1 to Day 3 Group Comparisons |
| Wilcoxon (Mann-Whitney) |
| 0.5622 |
| Superiority |
Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Basic Mobility Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.5538 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Participation Restriction Changes from Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.2310 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Social Roles Changes from Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.0435 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.6519 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Basic Mobility |
|
| Participation Restriction |
|
| Social Roles |
|
| Instrumental Roles |
|
Daily Activities Changes for Day 1 to Day 3 Group Comparisons |
| Wilcoxon (Mann-Whitney) |
| 0.7483 |
| Superiority |
Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Basic Mobility Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.4953 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Participation Restriction Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.8669 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Social Roles Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.8451 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons | Wilcoxon (Mann-Whitney) | 0.7376 | Superiority | Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons. |
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|
| Influenza B |
|
| Influenza B |
|
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|
| A/H3N2 - Baseline |
|
| A/H3N2 - Post-vaccination |
|
| Influenza B - Baseline |
|
| Influenza B - Post-vaccination |
|