NCT00161811CompletedPhase 2
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.
Alachua Government Services, Inc.8 sites in 2 countries1,400 target enrollmentStarted: November 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1,400
- Locations
- 8
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Investigators
Study Sites (8)
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