Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

Study Overview
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Brief Summary
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The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Official Title
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Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.

Conditions
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Influenza

Intervention / Treatment
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* Biological: Vero Cell-derived Influenza Vaccine
* Biological: Egg cell-derived Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects will be eligible for participation in this study if they: are >= 18 and <= 60 years old on the day of screening (for Stratum A only); are > 60 years old on the day of screening (for Stratum B only); are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); will reliably keep a daily record of symptoms; understand the nature of the study, agree to its provisions, and give written informed consent; if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season; suffer from any kind of immunodeficiency; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence the normal immunologic functions; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within 30 days of study entry; have donated blood or plasma within 30 days of study entry; have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications); have a rash or dermatological condition which may interfere with injection site reaction rating; have a known or suspected problem with drug or alcohol abuse; are unable to lead an independent life either physically or mentally; were administered an investigational drug within six weeks prior to study entry; are concurrently participating in a clinical study including the administration of an investigational product; if female, are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Vero Cell-derived Influenza Vaccine|nan|
|Biological: Egg cell-derived Influenza Vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |