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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Myxovirus Infection; Influenza; Orthomyxoviridae Infection

Treatments: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772109

FID31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,292 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,292 participants in 4 patient groups

Fluzone Intradermal Vaccine Lot 1

Experimental group

Description:

Participants will receive a dose of Influenza intradermal vaccine Lot 1

Treatment:

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: Influenza Virus Vaccine USP Trivalent Types A and B

Fluzone Intradermal Vaccine Lot 2

Experimental group

Description:

Participants will receive a dose of Influenza intradermal vaccine Lot 2

Treatment:

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: Influenza Virus Vaccine USP Trivalent Types A and B

Fluzone Intradermal Vaccine Lot 3

Experimental group

Description:

Participants will receive a dose of Influenza intradermal vaccine Lot 3

Treatment:

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: Influenza Virus Vaccine USP Trivalent Types A and B

Fluzone Intramuscular Vaccine

Active Comparator group

Description:

Participants will receive a dose of influenza intramuscular vaccine

Treatment:

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: Influenza Virus Vaccine USP Trivalent Types A and B