Clinical trial NCT00772109: Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Keywords: Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Fluzone®
Adults
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 4292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
timeFrame: Baseline (Day 0) and 28 Days post-vaccination
measure: Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: 28 Days post-vaccination
Secondary outcomes:
measure: Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
timeFrame: Before and 28 Days post-vaccination
measure: Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: Day 0 up to 7 Days post vaccination
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: San Diego
country: United States
state: California
city: Milford
country: United States
state: Connecticut
city: Melbourne
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Rockville
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mt. Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
city: Castellana Gardens, Carolina
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.