InfluenzaPhase 4NCT03068949
Comparison of Three Licensed Influenza Vaccines
A Phase 4 study testing FluBlok, Fluzone and FluCelVax in people with Influenza, run by University of Rochester at 1 site in United States.
Trial summary
This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluBlok, Fluzone and FluCelVax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2015to 30 Jun 2021
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 49 years of age (inclusive).
- Female subjects must fulfill one of the following: (i) not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii) agrees to practice effective methods of contraception that may include, but are not limited to abstinence, barrier methods, monogamous relationship with vasectomized partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30 days following receipt of the last dose of vaccine.
- Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
- The subject must be in good health, as determined by: vital signs (heart rate >55 to <100 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤150 mm Hg; diastolic ≤ 90 mm Hg; oral temperature <100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months.
- The subject is able to understand and comply with the planned study procedures, including being available for all study visits.
- The subject has provided informed consent prior to any study procedures.
- Subjects who have not received seasonal flu vaccine for the current year.
Who cannot join
- Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine.
- Subject report of known latex allergy
- Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
- Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine.
- The subject is a woman who is pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of vaccine.
- The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
Show all 19Show fewer
- The subject 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 hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- The subject has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days.
- The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include any acute or chronic medical disease or conditions defined as persisting for 3 months (defines ad 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study.
- Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9F (37.7C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved > 3 days prior to enrollment.
- The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
- The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
- The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.
- The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- The subject has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center, Vaccine Research Unit Room 3-5000
Rochester, New York, 14642
About this study
Official title: A Comparison of CD4 T Cell Induction and Antibody Responses Between a Pure Hemagglutinin Influenza Vaccine and Licensed Subvirion Influenza Vaccine Made in Eggs or Cell Culture in Healthy Adults.
This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.
Read the detailed description
Previous observations to date lead to the following model: Traditional egg-derived TIV have contaminating internal virion proteins that preferentially elicit memory CD4 T cells specific for these proteins. These CD4 T cells will have limited efficacy as helpers for the neutralizing Ab response and will suppress the CD4 T cell response to new HA epitopes in the vaccine. The current study will test this hypothesis by comparing CD4 cell responses to specific epitopes, and the subsequent B cell and antibody response, in subjects receiving a vaccine containing only HA protein to vaccines with more complex antigenic characteristics. The CD4 T cell reactivity to pools of unique, conserved, and total pH1 HA peptides as well as H3, influenza B HA, NP, and M1 peptides will be quantified using cytokine Elispot assays and flow cytometry, and then compared to the subsequent antibody and B cell response.
Investigators will also use this study as an opportunity to evaluate the effects of prior vaccination. Recent studies have emphasized the potential negative effect of vaccination in prior years on both the immune response as well as the protective effectiveness of current vaccine. In order to evaluate this phenomenon in the context of multiple vaccine formulations, prior vaccination history of the subjects will be reviewed and subjects stratify vaccination based on vaccine history.
In addition, subjects who participated in this study in a previous year are eligible to re-enroll, and will receive the same vaccine that they were randomized to previously. This will allow an evaluation of differences between vaccine formulations in the responsiveness to multiple vaccinations.
Furthermore, recent studies indicate reports that the glycosylation pattern of viral hemagglutinins produced in cell culture can vary depending on the host cell used, and that this can affect CD4 T cell immunogenicity and antibody recognition. As a cell culture-based influenza vaccine production platform offers many advantages and may eventually supplant the traditional egg-based approach, it is of great value to understand the CD4 T cell response induced by this vaccine and how this affects neutralizing Ab production.
Recent data have also suggested that the failure of seasonal influenza infection to induce substantial levels of stalk specific antibody may be due to the relatively inaccessible nature of this epitope. As part of this study, investigators will also compare the specificity of the human antibody response between the vaccine groups, with the hypothesis that the rHA vaccine will more readily allow targeting of these important, broadly conserved epitopes. There is compelling preliminary data demonstrating that multiple antibodies that we have isolated have a particularly slow on rate when they bind to the HA-stalk versus the HA-globular head epitopes on whole virions, but not on recombinant HA trimmers expressed in baculovirus. The hypothesis is that a free, recombinant HA vaccine will allow more efficient targeting of the HA-Stalk epitopes.
- Conditions
- Influenza
- Being tested
- FluBlok, Fluzone, FluCelVax, Fluzone HD
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluBlokBiological
FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
FluzoneBiological
Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
FluCelVaxBiological
FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
Fluzone HDBiological
Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| FluBlok | Active comparator | FluBlok 0.5 mL given IM X1 Receives: Biological: FluBlok |
| Fluzone | Active comparator | Fluzone 0.5 mL given IM X1 Receives: Biological: Fluzone |
| FluCelVax | Active comparator | FluCelVax 0.5 mL given IM X 1 Receives: Biological: FluCelVax |
| Fluzone HD | Active comparator | Fluzone HD 0.5 mL given IM X1 Receives: Biological: Fluzone HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1)
Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Measured: Day 0 to Day 28
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Measured: Day 0 to Day 28
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Measured: Day 0 to Day 28
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1)
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.
Measured: Day 0 to Day 28
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.
Measured: Day 0 to Day 28
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot
Measured: Day 0 to Day 14
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot
Measured: Day 0 to Day 14
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.
Measured: Day 0 to Day 14
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.
Measured: Day 0 to Day 14
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start28 Oct 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Angela Branche, University of Rochester
- Investigators
- Angela Branche, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068949
- Sponsor's protocol ID
- 59331
- Other IDs
- 272201400005C-P00019-9999-4
- Status last verified
- Nov 2021
- First submitted
- 23 Feb 2017
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the CEIRS (Centers of Excellence for Influenza Research and Surveillance) network
Publications
Gouma S, Zost SJ, Parkhouse K, Branche A, Topham DJ, Cobey S, Hensley SE. Comparison of Human H3N2 Antibody Responses Elicited by Egg-Based, Cell-Based, and Recombinant Protein-Based Influenza Vaccines During the 2017-2018 Season. Clin Infect Dis. 2020 Sep 12;71(6):1447-1453. doi: 10.1093/cid/ciz996.
PubMed 31598646
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of CD4 T Cell Induction and Antibody Responses Between a Pure Hemagglutinin Influenza Vaccine and Licensed Subvirion Influenza Vaccine Made in Eggs or Cell Culture in Healthy Adults.
- ClinicalTrials.gov ID
- NCT03068949
- Acronym / sponsor ID
- 59331
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.
Detailed description
Previous observations to date lead to the following model: Traditional egg-derived TIV have contaminating internal virion proteins that preferentially elicit memory CD4 T cells specific for these proteins. These CD4 T cells will have limited efficacy as helpers for the neutralizing Ab response and will suppress the CD4 T cell response to new HA epitopes in the vaccine. The current study will test this hypothesis by comparing CD4 cell responses to specific epitopes, and the subsequent B cell and antibody response, in subjects receiving a vaccine containing only HA protein to vaccines with more complex antigenic characteristics. The CD4 T cell reactivity to pools of unique, conserved, and total pH1 HA peptides as well as H3, influenza B HA, NP, and M1 peptides will be quantified using cytokine Elispot assays and flow cytometry, and then compared to the subsequent antibody and B cell response.
Investigators will also use this study as an opportunity to evaluate the effects of prior vaccination. Recent studies have emphasized the potential negative effect of vaccination in prior years on both the immune response as well as the protective effectiveness of current vaccine. In order to evaluate this phenomenon in the context of multiple vaccine formulations, prior vaccination history of the subjects will be reviewed and subjects stratify vaccination based on vaccine history.
In addition, subjects who participated in this study in a previous year are eligible to re-enroll, and will receive the same vaccine that they were randomized to previously. This will allow an evaluation of differences between vaccine formulations in the responsiveness to multiple vaccinations.
Furthermore, recent studies indicate reports that the glycosylation pattern of viral hemagglutinins produced in cell culture can vary depending on the host cell used, and that this can affect CD4 T cell immunogenicity and antibody recognition. As a cell culture-based influenza vaccine production platform offers many advantages and may eventually supplant the traditional egg-based approach, it is of great value to understand the CD4 T cell response induced by this vaccine and how this affects neutralizing Ab production.
Recent data have also suggested that the failure of seasonal influenza infection to induce substantial levels of stalk specific antibody may be due to the relatively inaccessible nature of this epitope. As part of this study, investigators will also compare the specificity of the human antibody response between the vaccine groups, with the hypothesis that the rHA vaccine will more readily allow targeting of these important, broadly conserved epitopes. There is compelling preliminary data demonstrating that multiple antibodies that we have isolated have a particularly slow on rate when they bind to the HA-stalk versus the HA-globular head epitopes on whole virions, but not on recombinant HA trimmers expressed in baculovirus. The hypothesis is that a free, recombinant HA vaccine will allow more efficient targeting of the HA-Stalk epitopes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FluBlok | Active comparator | Biological: FluBlokFluBlok 0.5 mL given IM X1 |
| Fluzone | Active comparator | Biological: FluzoneFluzone 0.5 mL given IM X1 |
| FluCelVax | Active comparator | Biological: FluCelVaxFluCelVax 0.5 mL given IM X 1 |
| Fluzone HD | Active comparator | Biological: Fluzone HDFluzone HD 0.5 mL given IM X1 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 18 and 49 years of age (inclusive).
- Female subjects must fulfill one of the following: (i) not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii) agrees to practice effective methods of contraception that may include, but are not limited to abstinence, barrier methods, monogamous relationship with vasectomized partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30 days following receipt of the last dose of vaccine.
- Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
- The subject must be in good health, as determined by: vital signs (heart rate >55 to <100 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤150 mm Hg; diastolic ≤ 90 mm Hg; oral temperature <100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months.
- The subject is able to understand and comply with the planned study procedures, including being available for all study visits.
Key exclusion criteria (19 listed)
- Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine.
- Subject report of known latex allergy
- Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
- Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine.
- The subject is a woman who is pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of vaccine.
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 |
|---|---|---|
| FluBlokFluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly | Biological | FluBlok |
| FluzoneFluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly | Biological | Fluzone |
| FluCelVaxFluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly | Biological | FluCelVax |
| Fluzone HDFluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly | Biological | Fluzone HD |
Primary outcome
Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1)
Time frame: Day 0 to Day 28
Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Time frame: Day 0 to Day 28
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Time frame: Day 0 to Day 28
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1)
Time frame: Day 0 to Day 28
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Time frame: Day 0 to Day 28
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA
Time frame: Day 0 to Day 14
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA
Time frame: Day 0 to Day 14
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA
Time frame: Day 0 to Day 14
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP
Time frame: Day 0 to Day 14
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1
Time frame: Day 0 to Day 14
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31598646Gouma S, Zost SJ, Parkhouse K, Branche A, Topham DJ, Cobey S, Hensley SE. Comparison of Human H3N2 Antibody Responses Elicited by Egg-Based, Cell-Based, and Recombinant Protein-Based Influenza Vaccines During the 2017-2018 Season. Clin Infect Dis. 2020 Sep 12;71(6):1447-1453. doi: 10.1093/cid/ciz996.
- Individual participant dataSharing planned: Yes. Data will be shared with the CEIRS (Centers of Excellence for Influenza Research and Surveillance) network
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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.
Angela Branche, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FluBlok, Fluzone and FluCelVax in people with Influenza, run by University of Rochester at 1 site 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 7 inclusion and 19 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nov 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?
Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1) (time frame: Day 0 to Day 28). The study lists 10 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 NCT03068949, 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 30 Nov 2021.