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
Influenza
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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.
Sites / Locations
- Vienna General Hospital (AKH), Department of Clinical Pharmacology
- Neuendorfstr. 20
- Münstererstr. 1a
- Mainz University Children´s Clinic