Influenza
Conditions
Brief summary
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.
Interventions
BIOLOGICALVero Cell-derived Influenza Vaccine
BIOLOGICALEgg cell-derived Influenza Vaccine
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Countries
Austria, Germany
Outcome results
None listed