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

NCT01011049 | Completed Phase 2 Results

• 2 other identifiers: FID33UTN: U1111-1111-5095
• Study Type: interventional
• Target: 1,250
• Locations: 2 countries
• Sites: 45

Brief 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. Secondary Objective:
• To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Conditions

Influenza

Keywords

Influenza; Fluzone Vaccine; Intradermal Injections; Adults

Outcome Measures

Primary Outcomes (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).

  Day 0 through Day 7 post-vaccination

Secondary Outcomes (3)

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

  Day 0 and Day 28 post-vaccination

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

  Day 28 post-vaccination

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

  Day 28 post vaccination

Study Arms (4)

Group 1: Fluzone ID After Fluzone ID

EXPERIMENTAL

Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 2: Fluzone IM After Fluzone ID

EXPERIMENTAL

Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 3: Fluzone IM After Fluzone IM

EXPERIMENTAL

Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 4: Fluzone ID After Fluzone IM

EXPERIMENTAL

Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Interventions

Influenza Virus Vaccine USP Trivalent Types A and B BIOLOGICAL

0.1 mL, Intradermal

Group 1: Fluzone ID After Fluzone ID

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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).

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (45)

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Hoover, Alabama, 35216, United States

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Huntsville, Alabama, 35802, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85213, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85711, United States

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Fountain Valley, California, 92708, United States

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San Diego, California, 92103, United States

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Milford, Connecticut, 06460, United States

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Melbourne, Florida, 32935, United States

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Pembroke Pines, Florida, 33024, United States

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Pinellas Park, Florida, 33781, United States

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Boise, Idaho, 83642, United States

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Chicago, Illinois, 60610, United States

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Iowa City, Iowa, 52242, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Madisonville, Kentucky, 42431, United States

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Rockville, Maryland, 20850, United States

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Kansas City, Missouri, 64114, United States

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Springfield, Missouri, 65802, United States

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St Louis, Missouri, 63104, United States

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Albuquerque, New Mexico, 87108, United States

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Binghamton, New York, 13901, United States

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Endwell, New York, 13760, United States

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Rochester, New York, 14609, United States

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Rochester, New York, 14621, United States

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Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45249, United States

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Allentown, Pennsylvania, 18102, United States

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Bensalem, Pennsylvania, 19020, United States

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Warwick, Rhode Island, 02886, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Fort Worth, Texas, 76107, United States

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Fort Worth, Texas, 76135, United States

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San Angelo, Texas, 76904, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Jordan, Utah, 84088, United States

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Marshfield, Wisconsin, 54449, United States

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San Juan, 00918, Puerto Rico

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Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 14, 2016
• Results First Posted: August 11, 2011

Record last verified: 2016-04

Locations

PR (1); US (44)