Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Study Overview
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Brief Summary
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Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

Official Title
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Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.

Conditions
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Influenza

Intervention / Treatment
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* Biological: Cell-Derived Trivalent Subunit Influenza Vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Willing and able to give informed consent and able to adhere to all protocol required study procedures. Men and women aged >= 18 and <= 64 years. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria Known to be allergic to constituents of the vaccine. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Cell-Derived Trivalent Subunit Influenza Vaccine<br>* surface antigen, inactivated, prepared in cell cultures<br>|
| Placebo Comparator: 2<br> | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. |  | 3 weeks | 
| To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. |  | 6 months | 
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. |  | 3 weeks | 
| To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Placebo-controlled, Phase II