Clinical trial NCT01011049: Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Fluzone Vaccine
Intradermal Injections
Adults
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 1250
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: 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.

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.

Eligibility criteria: Inclusion Criteria :

* 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

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 (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
* 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.

Primary outcomes:
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: Day 0 through Day 7 post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: Day 0 and Day 28 post-vaccination
measure: Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.
timeFrame: Day 28 post-vaccination
measure: Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: Day 28 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: Tempe
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: 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: Marshfield
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: