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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

Conditions
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Influenza, Orthomyxoviruses, Myxovirus Infection

Intervention / Treatment
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* Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
* Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
* Biological: Influenza virus vaccine (2007-2008 Formulation)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Standard-dose Cell-based Influenza Vaccine<br>Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. | Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 2: High-dose Cell-based Influenza Vaccine<br>Participants will receive a single dose of high-dose cell-based influenza virus vaccine. | Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)<br>* 1.0 mL, Intramuscular<br>|
| Active Comparator: Group 3: Licensed Fluzone® Influenza Vaccine<br>Participants will receive a single dose of licensed Fluzone® influenza vaccine. | Biological: Influenza virus vaccine (2007-2008 Formulation)<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone® (2007-2008 formulation);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. |  | Days 0 and 21 post-vaccination | 
| Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ) | Day 21 post-vaccination | 
| Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21. | Day 21 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors. | Day 0 up to Day 7 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Orthomyxoviruses, Split-virion inactivated influenza vaccine, cell-based vaccine, Adults