InfluenzaPhase 4FLU-LNNCT03898973
Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
A Phase 4 study testing Quadrivalent inactivated influenza vaccine (IIV) in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent inactivated influenza vaccine (IIV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 17 Nov 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-75-year-old male and female patients
- Body mass index (BMI) 20-35 kg/m2
- Acceptable laboratory values: Absolute neutrophil count (ANC) > 750 cells/mm3; Hemoglobin >10 g/dL; Platelet count >75,000/mm3; Partial thromboplastin time (PTT) >1.2x ULN; Prothrombin time (PT) >1.2x ULN
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study
- Acceptable medical history by review of inclusion/exclusion criteria
Who cannot join
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products or to vaccine components
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
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- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
- Receipt of blood or blood products within the past 6 months or planned used during the study.
- A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
- Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
- Need for allergy immunization (that cannot be postponed) until after the last study visit.
- History of Guillain-Barre# syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
- Pregnancy
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety,
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center, Lane building L134
Stanford, California, 94305
About this study
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.
Read the detailed description
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.
Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.
The study has a total of 3 visits.
Study Procedures:
Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).
Visit 1: Vaccination Visit:
Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination.
Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.
- Conditions
- Influenza
- Being tested
- Quadrivalent inactivated influenza vaccine (IIV)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent inactivated influenza vaccine (IIV)Biological
Also called Fluzone Quadrivalent
Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
| Study group | Role | What they receive |
|---|---|---|
| Study Phase | Other | Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV) Receives: Biological: Quadrivalent inactivated influenza vaccine (IIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAI titer
This measures response to influenza vaccine
Measured: Day 7 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start11 Apr 2019
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Were not able to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Philip Grant, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898973
- Sponsor's protocol ID
- 50328
- Acronym
- FLU-LN
- Status last verified
- May 2022
- First submitted
- 30 Mar 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
- ClinicalTrials.gov ID
- NCT03898973
- Acronym / sponsor ID
- FLU-LN / 50328
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Were not able to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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 is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.
Detailed description
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.
Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.
The study has a total of 3 visits.
Study Procedures:
Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).
Visit 1: Vaccination Visit:
Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination.
Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Phase | Other | Biological: Quadrivalent inactivated influenza vaccine (IIV)Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20-75-year-old male and female patients
- Body mass index (BMI) 20-35 kg/m2
- Acceptable laboratory values: Absolute neutrophil count (ANC) > 750 cells/mm3; Hemoglobin >10 g/dL; Platelet count >75,000/mm3; Partial thromboplastin time (PTT) >1.2x ULN; Prothrombin time (PT) >1.2x ULN
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study
Key exclusion criteria (22 listed)
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products or to vaccine components
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
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 |
|---|---|---|
| Quadrivalent inactivated influenza vaccine (IIV)Also: Fluzone QuadrivalentIntramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps. | Biological | Study Phase |
Primary outcome
HAI titer
Time frame: Day 7 after vaccination
This measures response to influenza vaccine
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Quadrivalent inactivated influenza vaccine (IIV) in people with Influenza, run by Stanford University 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 6 inclusion and 22 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: withdrawn, as of the sponsor's last update on 21 Nov 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
HAI titer (time frame: Day 7 after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.