Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine
Eligibility Criteria
Inclusion Criteria: Male and female subjects will be eligible for participation in this study if they: are >= 18 and <= 60 years old (for Stratum A only); are > 60 years old (for Stratum B only); are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial; 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 - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Male and female subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 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 immunological functions; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within one month of study entry; have a history of any vaccine-related contraindicating event (e.g. anaphylaxis); 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; had administration of an investigational drug within six weeks prior to the study start; are concurrently participating in a clinical trial; are pregnant or lactating.
Sites / Locations
- PANTAMED Sp.z o.o.