AzTrials
AzTrials

InfluenzaPhase 4NCT02141581

Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)

A Phase 4 study testing Fluzone® (IM), Fluzone® Intradermal (ID) and 2011-2012 FluMist® in people with Influenza, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female… Read more about this study

Who is it for?
Ages 8 to 34 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Fluzone® (IM), Fluzone® Intradermal (ID) and 2011-2012 FluMist®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteUnited States
Study dates
Aug 2011to Dec 2014
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 8 to 34 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Otherwise healthy, ambulatory between the ages of 8-33 years, inclusively.
  • Willing to complete the informed consent process
  • Availability for follow-up for the planned duration of the study at least 28 days after immunization
  • Acceptable medical history and vital signs

Who cannot join

  • Prior vaccination with seasonal TIV or LAIV
  • Prior off-study vaccination with TIV or LAIV in the current flu season
  • Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose vials only)
  • Life-threatening reactions to previous influenza vaccinations
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • Asthma or history of wheezing (for volunteers receiving LAIV only)
Show all 26Show fewer
  • Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for volunteers receiving LAIV only)
  • History of immunodeficiency (including HIV infection)
  • Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol
  • Blood pressure >150 systolic or >95 diastolic at first study visit
  • Chronic Hepatitis B or C
  • Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids are permissible in both groups)
  • 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. aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety
  • Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits
  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  • Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
  • Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
  • Need an allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28)
  • History of Guillain-Barré Syndrome
  • Pregnant or lactating woman
  • Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits
  • Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of study visits
  • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford LPCH Vaccine Program

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Vaccination and Infection: Indicators of Immunological Health and Responsiveness. Project 1: Plasmablast Trafficking and Antibody Response in Influenza Vaccination;

The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female adult volunteers.

Read the detailed description

The aim of this study is to compare the response to different formulations of licensed influenza vaccines.

The type of seasonal influenza vaccination(s) received independently by volunteers in the year(s) since their last study visit will not impact eligibility. Volunteers will be assigned into one of three vaccine groups (intramuscular trivalent inactivated influenza vaccine (TIV); live attenuated influenza vaccine (LAIV- given year 1 only) or intradermal TIV, based on the type of study vaccine they received in 2010, 2011, 2012, or 2013. All participants will receive a single dose of their assigned seasonal influenza vaccine. Volunteers will complete 3 study visits at Day 0, Day 6-8 and Day 24-32.

Conditions
Influenza
Being tested
Fluzone® (IM), Fluzone® Intradermal (ID), 2011-2012 FluMist®
Keywords
Intramuscular inactivated trivalent influenza vaccine, Intradermal inactivated trivalent influenza vaccine, Live, attenuated influenza vaccine, Young adults
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluzone® (IM)Biological

    Also called Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine

    This vaccine is given intramuscularly (IM)

  • Fluzone® Intradermal (ID)Biological

    Also called Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal Influenza Vaccine

    This vaccine is given intradermally (ID)

  • 2011-2012 FluMist®Biological

    Also called Live, attenuated influenza vaccine (LAIV), FDA-licensed seasonal influenza vaccine

    This vaccine is given intranasally

Study groups in NCT02141581
Study groupRoleWhat they receive
Group A Fluzone® (IM)ExperimentalParticipants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone®, administered intramuscularly (IM) 2011-2012, 2012-2013 or 2013-2014 Fluzone was used as appropriate for the current year of study
Receives: Biological: Fluzone® (IM)
Group B Fluzone® Intradermal (ID)ExperimentalParticipants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone® Intradermal, administered intradermally (ID) 2011-2012, 2012-2013 or 2013-2014 Fluzone Intradermal was used as appropriate for the current year of study
Receives: Biological: Fluzone® Intradermal (ID)
Group C 2011-2012 FluMist®ExperimentalParticipants in this group will be randomized to 2011-2012 live attenuated influenza vaccine, FluMist®, administered intranasally. FluMist was only used in the first year of study.
Receives: Biological: 2011-2012 FluMist®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants From Each Arm Who Received Influenza Vaccine

    Measured: Baseline to Day 28

Secondary outcomes (1)

  1. Number of Participants With Related Adverse Events

    Number of participants with Related Adverse Events with a 0% Frequency Threshold

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2014 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02141581
Sponsor's protocol ID
SU-21987- 2011
Other IDs
1U19AI090019-01
Status last verified
Apr 2018
First submitted
15 May 2014
Last updated
7 May 2018
Data monitoring committee
No
Individual data sharing
Yes: The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.

Publications

  • Vollmers C, Sit RV, Weinstein JA, Dekker CL, Quake SR. Genetic measurement of memory B-cell recall using antibody repertoire sequencing. Proc Natl Acad Sci U S A. 2013 Aug 13;110(33):13463-8. doi: 10.1073/pnas.1312146110. Epub 2013 Jul 29.

    PubMed 23898164

  • He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21.

    PubMed 25336731

  • Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.

    PubMed 27655870

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluzone® (IM), Fluzone® Intradermal (ID) and 2011-2012 FluMist® 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 4 inclusion and 26 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 7 May 2018. 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 11 May 2017). 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 From Each Arm Who Received Influenza Vaccine (time frame: Baseline to Day 28). 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 NCT02141581, which also lists 3 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 7 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in