PainPhase 4NCT03183908
FLUAD® vs. Fluzone® High-Dose Study
A Phase 4 study testing FLUAD® and Fluzone® High-Dose in people with Pain and Quality of Life, run by Duke University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Quality of Life, Injection Site Reaction
- What is being tested?
- FLUAD® and Fluzone® High-Dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Aug 2017to 14 Feb 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Persons aged ≥65 years, living in the community
- Intention of receiving IIV vaccine based on ACIP-CDC guidelines
- Willing to provide written informed consent prior to initiation of any study procedures
- Able to speak English
- Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record
- Able and willing to complete post-vaccine assessments and questionnaires independently or with assistance
Show all 11Show fewer
- Able and willing to have blood drawn for the study
- Able and willing to return in about one month for a follow-up visit including completing questionnaires and having another blood test
- Access to and ability to use a phone, independently or with assistance
- Adequate vision and motor skills to complete the diary form independently or with assistance.
- Not living in a skilled nursing facility/nursing home/long term acute care facility
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Boston Medical Center
Boston, Massachusetts, 02118
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27705
About this study
Official title: Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults
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.
Read the 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.
- Being tested
- FLUAD®, Fluzone® High-Dose
- Keywords
- influenza vaccine, fever following vaccination, pain following vaccination, quality of life
- Medical subject headings
- Pain, Injection Site Reaction, Drug-Related Side Effects and Adverse Reactions, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUAD®Biological
Also called Adjuvanted influenza vaccine
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Fluzone® High-DoseBiological
Also called High-dose influenza vaccine
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Adjuvanted influenza vaccine (FLUAD®) | Active comparator | In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1. Receives: Biological: FLUAD® |
| 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. Receives: Biological: Fluzone® High-Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 29 days post-vaccination
Secondary outcomes (24)
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.
Measured: Days 1 through 8 post-vaccination
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 29 (28 days post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start28 Aug 2017
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston Medical Center, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Kenneth Schmader, MD, Principal investigator, Duke UniversityTheresa Harrington, MD, Principal investigator, Centers for Disease Control and PreventionElizabeth Barnett, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183908
- Sponsor's protocol ID
- Pro00083845
- Status last verified
- Mar 2021
- First submitted
- 7 Jun 2017
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37393237Schmader 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.
PubMed 33443580
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults
- ClinicalTrials.gov ID
- NCT03183908
- Acronym / sponsor ID
- Pro00083845
- Keywords
- influenza vaccine, fever following vaccination, pain following vaccination, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston Medical Center, Children's Hospital Medical Center, Cincinnati
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvanted influenza vaccine (FLUAD®) | Active comparator | Biological: FLUAD®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 | Biological: Fluzone® High-DoseIn the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Persons aged ≥65 years, living in the community
- Intention of receiving IIV vaccine based on ACIP-CDC guidelines
- Willing to provide written informed consent prior to initiation of any study procedures
- Able to speak English
- Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record
Key exclusion criteria (18 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUAD®Also: Adjuvanted influenza vaccineAdvisory Committee on Immunization Practices (ACIP) Recommended Vaccine | Biological | Adjuvanted influenza vaccine (FLUAD®) |
| Fluzone® High-DoseAlso: High-dose influenza vaccineAdvisory Committee on Immunization Practices (ACIP) Recommended Vaccine | Biological | High-dose influenza vaccine (Fluzone® HD) |
Primary outcome
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
24 secondary outcomes
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Time frame: Days 1 through 8 post-vaccination
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Time frame: Days 1 through 8 post-vaccination
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Time frame: Days 1 through 8 post-vaccination
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Time frame: Days 1 through 8 post-vaccination
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Time frame: Days 1 through 8 post-vaccination
Number of Participants With System Reactions - Ages 80 +, Population 1
Time frame: Days 1 through 8 post-vaccination
Quality of Life - Late Life Function & Disability Instrument - Full Population
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L -Full Population
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L - Ages 65 - 79
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L - Ages 80 +
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS -Full Population
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS - Ages 65 - 79
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS - Ages 80 +
Time frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Seroconversion - 65 and Older
Time frame: Day 29 (28 days post-vaccination)
Seroprotection - 65 and Older
Time frame: Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - 65 and Older
Time frame: Day 29 (28 days post-vaccination)
Seroconversion - Ages 65-79
Time frame: Day 29 (28 days post-vaccination)
Seroconversion - Ages 80 and Older
Time frame: Day 29 (28 days post-vaccination)
Seroprotection - Ages 65-79
Time frame: Day 29 (28 days post-vaccination)
Seroprotection - Ages 80 and Older
Time frame: Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - Ages 65-79
Time frame: Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - Ages 80 and Older
Time frame: Day 29 (28 days post-vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37393237Schmader 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.
- Derived from this study: PubMed 33443580Schmader 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Schmader, MD principal investigator
Duke University
Theresa Harrington, MD principal investigator
Centers for Disease Control and Prevention
Elizabeth Barnett, MD principal investigator
Boston University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FLUAD® and Fluzone® High-Dose in people with Pain and Quality of Life, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1 (time frame: Days 1 through 8 post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183908, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.