Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Condition(s) targeted: Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Intervention: Influenza Virus Vaccine USP Trivalent Types A and B (Biological); Influenza Virus Vaccine USP Trivalent Types A and B (Biological); Influenza Virus Vaccine USP Trivalent Types A and B (Biological); Influenza Virus Vaccine USP Trivalent Types A and B (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Sanofi Pasteur Inc.

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective:

- To demonstrate lot consistency of the Fluzone ID manufacturing process.

- To provide information concerning the immune response of Fluzone ID.

Secondary Objectives: Safety

- To describe the safety profile of subjects who receive of Fluzone ID.

Official title: Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines

Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine

Secondary outcome:

Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine

Detailed description: Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria :

- Aged 18 to 64 years on the day of vaccination.

- Informed consent form signed and dated.

- Able to attend all scheduled visits and to comply with all trial procedures.

- For women 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. Exclusion Criteria :

- 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.

- 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.

- Previous vaccination against influenza in the past 6 months with the trial vaccine or

another vaccine.

- Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.

- 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, (except localized skin or prostate

cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).

- Personal or family history of Guillain-Barré Syndrome.

Castellana Gardens, Carolina 00983, Puerto Rico

San Juan 00918, Puerto Rico

San Juan 00935, Puerto Rico

Hoover, Alabama 35216, United States

Huntsville, Alabama 35802, United States

Mobile, Alabama 36608, United States

Chandler, Arizona 85224, United States

Mesa, Arizona 85213, United States

Phoenix, Arizona 85014, United States

Tucson, Arizona 85711, United States

Fountain Valley, California 92708, United States

San Diego, California 92103, United States

Milford, Connecticut 06460, United States

Melbourne, Florida 32935, United States

Pembroke Pines, Florida 33024, United States

Pinellas Park, Florida 33781, United States

Boise, Idaho 83642, United States

Chicago, Illinois 60610, United States

Iowa City, Iowa 52242, United States

Wichita, Kansas 67207, United States

Lexington, Kentucky 40509, United States

Madisonville, Kentucky 42431, United States

Rockville, Maryland 20850, United States

Kansas City, Missouri 64114, United States

Springfield, Missouri 65802, United States

St. Louis, Missouri 63104, United States

Albuquerque, New Mexico 87108, United States

Binghamton, New York 13901, United States

Endwell, New York 13760, United States

Rochester, New York 14609, United States

Rochester, New York 14621, United States

Cary, North Carolina 27518, United States

Raleigh, North Carolina 27609, United States

Cincinnati, Ohio 45249, United States

Allentown, Pennsylvania 18102, United States

Bensalem, Pennsylvania 19020, United States

Warwick, Rhode Island 02886, United States

Mt. Pleasant, South Carolina 29464, United States

Nashville, Tennessee 37203, United States

Austin, Texas 78705, United States

Fort Worth, Texas 76107, United States

Fort Worth, Texas 76135, United States

Galveston, Texas 77555, United States

San Angelo, Texas 76904, United States

Salt Lake City, Utah 84121, United States

Salt Lake, Utah 84109, United States

West Jordan, Utah 84088, United States

Seattle, Washington 98101, United States

Marshfield, Wisconsin 54449, United States

Starting date: October 2008
Last updated: January 9, 2014