Elderly Immune SystemPhase 4NCT02297542
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
A Phase 4 study testing Flu Vaccine in people with Elderly Immune System, run by Health Sciences North Research Institute at 2 sites in 2 countries.
Trial summary
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly Immune System
- What is being tested?
- Flu Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2014to 21 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent provided by the participant
- Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
- Willing to receive influenza vaccination
- Older cohort has received their influenza vaccine for the previous influenza season
- -
Who cannot join
- Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
- Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
- Participant has received a community available influenza vaccine for the approaching influenza season
- Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Center on Aging, UConn Health
Farmington, Connecticut, 06030
Canada1 site
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1
About this study
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
- Conditions
- Elderly Immune System
- Being tested
- Flu Vaccine
- Keywords
- Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu VaccineBiological
Also called Fluzone HD
| Study group | Role | What they receive |
|---|---|---|
| Flu Vaccine SD | Active comparator | Fluzone Standard Dose Influenza Vaccine Receives: Biological: Flu Vaccine |
| Flu Vaccine HD | Active comparator | Fluzone High Dose Influenza Vaccine Receives: Biological: Flu Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Influenza Cases
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start1 Feb 2014
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly Immune SystemStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health
- Responsible party
- Sponsor
- Investigators
- Janet E McElhaney, MD, Principal investigator, Health Sciences North Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297542
- Sponsor's protocol ID
- NIH R01
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2014
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
McElhaney JE, Verschoor CP, Haynes L, Pawelec G, Loeb M, Andrew MK, Kuchel GA. Key Determinants of Cell-Mediated Immune Responses: A Randomized Trial of High Dose Vs. Standard Dose Split-Virus Influenza Vaccine in Older Adults. Front Aging. 2021 May;2:649110. doi: 10.3389/fragi.2021.649110. Epub 2021 May 21.
PubMed 35128529
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02297542
- Acronym / sponsor ID
- NIH R01
- Conditions
- Elderly Immune System
- Keywords
- Influenza Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Collaborators
- UConn Health
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flu Vaccine SD | Active comparator | Biological: Flu VaccineFluzone Standard Dose Influenza Vaccine |
| Flu Vaccine HD | Active comparator | Biological: Flu VaccineFluzone High Dose Influenza Vaccine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent provided by the participant
- Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
- Willing to receive influenza vaccination
- Older cohort has received their influenza vaccine for the previous influenza season
- -
Key exclusion criteria (5 listed)
- Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
- Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
- Participant has received a community available influenza vaccine for the approaching influenza season
- Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
- -
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 |
|---|---|---|
| Flu VaccineAlso: Fluzone HD | Biological | Flu Vaccine HD, Flu Vaccine SD |
Primary outcome
Number of Influenza Cases
Time frame: five years
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 35128529McElhaney JE, Verschoor CP, Haynes L, Pawelec G, Loeb M, Andrew MK, Kuchel GA. Key Determinants of Cell-Mediated Immune Responses: A Randomized Trial of High Dose Vs. Standard Dose Split-Virus Influenza Vaccine in Older Adults. Front Aging. 2021 May;2:649110. doi: 10.3389/fragi.2021.649110. Epub 2021 May 21.
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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.
Janet E McElhaney, MD principal investigator
Health Sciences North Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flu Vaccine in people with Elderly Immune System, run by Health Sciences North Research Institute at 2 sites in 2 countries.
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 5 inclusion and 5 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Influenza Cases (time frame: five years). 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 NCT02297542, which also lists 1 linked publication.
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 5 Oct 2026.