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InfluenzaPhase 4NCT03020537

B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

A Phase 4 study testing Fluzone in people with Influenza, run by Stanford University.

Completed

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

Official record
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Trial summary

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults. Read more about this study

Who is it for?
Ages 1 year to 30 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Fluzone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
Oct 2013to Dec 2013
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 1 year to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.
  • Willing to complete the informed consent process.
  • Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B).
  • Acceptable medical history by medical history and vital signs.

Who cannot join

  • Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).
  • Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV
  • Allergy to egg or egg products, or to vaccine components.
  • Life-threatening reactions to previous influenza vaccinations
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immunodeficiency (including HIV infection)
Show all 23Show fewer
  • 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.
  • 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 inhaled steroids, or 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 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
  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  • Inactivated vaccine within 14 days prior to study vaccination (inform study staff of any non-study vaccinations received during study period)
  • Live, attenuated vaccine within 30 days prior to first study vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during study period).
  • Need for allergy immunizations (that cannot be rescheduled if necessary) during the study period
  • History of Guillain-Barre 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
  • 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.

About this study

Official title: U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 5, 2013

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.

Read the detailed description

This is a study of healthy children and adults who will be given standard seasonal influenza vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review and confirmation of written informed consent, volunteers will be enrolled into the study.

The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization), Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline blood sample will be drawn prior to immunization at Day 0, followed by two additional blood samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample collected at Day 28-32.

The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013 seasonal influenza vaccine. Participants in Group B will receive a single dose of the 2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3 blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be drawn prior to immunization at Day 0.

Conditions
Influenza
Being tested
Fluzone
Keywords
Trivalent inactivated influenza vaccine, Young children, 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.

  • FluzoneBiological

    Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.

Study groups in NCT03020537
Study groupRoleWhat they receive
Group A: 1-2 years oldOtherGroup A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Receives: Biological: Fluzone
Group B: 18-30 years oldOtherGroup B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Receives: Biological: Fluzone

What is being measured

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

  1. Number of Participants Who Received Influenza Vaccine

    Measured: Day 0 to 28

Secondary outcomes (1)

  1. Number of Participants With Related Adverse Events

    Measured: Day 0 to 28 post-immunization

Timeline

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

  1. First posted13 Jan 2017 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03020537
Sponsor's protocol ID
SU-17218-2013
Other IDs
2U19AI057229-06
Status last verified
May 2018
First submitted
11 Jan 2017
Last updated
6 Jun 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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 in people with Influenza, run by Stanford University.

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 23 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

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 9 Mar 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 Who Received Influenza Vaccine (time frame: Day 0 to 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 NCT03020537, 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 6 Jun 2018.

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