Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Sanofi

Status and phase: Completed; Phase 2

Conditions: Myxovirus Infection; Influenza; Orthomyxoviruses

Treatments: Biological: Influenza virus vaccine - cell based (2007-2008 Formulation); Biological: Influenza virus vaccine (2007-2008 Formulation); Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845429

GCE03

Details and patient eligibility

About

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Full description

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Enrollment: 729 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion
• Informed consent form signed
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination

Exclusion Criteria :

• Subject currently breast-feeding.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
• Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
• Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
• Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
• Receipt of blood or blood-derived products in the 3 months preceding vaccination.
• Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
• History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
• Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
• Planned receipt of any other 2007-2008 influenza vaccine.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• History of Guillain-Barré syndrome
• Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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729 participants in 3 patient groups

Group 1: Standard-dose Cell-based Influenza Vaccine

Experimental group

Description:

Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.

Treatment:

Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)

Group 2: High-dose Cell-based Influenza Vaccine

Experimental group

Description:

Participants will receive a single dose of high-dose cell-based influenza virus vaccine.

Treatment:

Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)

Group 3: Licensed Fluzone® Influenza Vaccine

Active Comparator group

Description:

Participants will receive a single dose of licensed Fluzone® influenza vaccine.

Treatment:

Biological: Influenza virus vaccine (2007-2008 Formulation)