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InfluenzaPhase 2NCT01011049

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

A Phase 2 study testing Influenza Virus Vaccine USP Trivalent Types A and B in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 45 sites in 2 countries.

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

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Influenza Virus Vaccine USP Trivalent Types A and B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,250 participants
Where
45 sitesin 2 countries
Study dates
Sep 2009to Oct 2010
Phase
Phase 2
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18 to 64 years on the day of vaccination in study FID33
  • Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) for the group to which they were randomized
  • Informed consent form signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

Who cannot join

  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period (observational trials will be allowed)
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
Show all 21Show fewer
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccination in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity.
  • Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Neoplastic disease or any hematologic malignancy, (those who have localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years will not be excluded).
  • Personal or family history of Guillain-Barré Syndrome
  • Temporary Exclusion Criteria:
  • A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
  • Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
  • Signs and symptoms of an acute infectious respiratory illness.

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

United States44 sites

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Allentown, Pennsylvania, 18102

  • Study site

    Austin, Texas, 78705

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Binghamton, New York, 13901

  • Study site

    Boise, Idaho, 83642

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chicago, Illinois, 60610

  • Study site

    Cincinnati, Ohio, 45249

  • Study site

    Endwell, New York, 13760

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Hoover, Alabama, 35216

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Melbourne, Florida, 32935

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Rochester, New York, 14609

  • Study site

    Rochester, New York, 14621

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Angelo, Texas, 76904

  • Study site

    San Diego, California, 92103

  • Study site

    Springfield, Missouri, 65802

  • Study site

    St Louis, Missouri, 63104

  • Study site

    Tempe, Arizona, 85282

  • Study site

    Tucson, Arizona, 85711

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wichita, Kansas, 67207

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

  • To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

  • To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
Read the detailed description

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

Conditions
Influenza
Being tested
Influenza Virus Vaccine USP Trivalent Types A and B
Keywords
Influenza, Fluzone Vaccine, Intradermal Injections, 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.

  • Influenza Virus Vaccine USP Trivalent Types A and BBiological

    0.1 mL, Intradermal

  • Influenza Virus Vaccine USP Trivalent Types A and BBiological

    Also called Fluzone® 2009/2010 Northern Hemisphere Formulation

    0.5 mL, Intramuscular

  • Influenza Virus Vaccine USP Trivalent Types A and BBiological

    Also called Fluzone® 2009/2010 Northern Hemisphere Formulation

    0.5 mL, Intramuscular

  • Influenza Virus Vaccine USP Trivalent Types A and BBiological

    0.1 mL, Intradermal

Study groups in NCT01011049
Study groupRoleWhat they receive
Group 1: Fluzone ID After Fluzone IDExperimentalParticipants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Group 2: Fluzone IM After Fluzone IDExperimentalParticipants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Group 3: Fluzone IM After Fluzone IMExperimentalParticipants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Group 4: Fluzone ID After Fluzone IMExperimentalParticipants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31
Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

What is being measured

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

  1. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine

    Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).

    Measured: Day 0 through Day 7 post-vaccination

Secondary outcomes (3)

  1. Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine

    Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.

    Measured: Day 0 and Day 28 post-vaccination

  2. Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.

    Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.

    Measured: Day 28 post-vaccination

  3. Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine

    Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.

    Measured: Day 28 post vaccination

Timeline

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

  1. First posted11 Nov 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2010
  4. Study completionOct 2010

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011049
Sponsor's protocol ID
FID33
Other IDs
UTN: U1111-1111-5095
Status last verified
Apr 2016
First submitted
9 Nov 2009
Last updated
14 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza Virus Vaccine USP Trivalent Types A and B in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 45 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 21 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Aug 2011). 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 Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine (time frame: Day 0 through Day 7 post-vaccination). 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 NCT01011049.

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 14 Apr 2016.

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