Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2008 |
End Date: | July 2009 |
Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older
The purpose of this study is to demonstrate the effectiveness (seroprotection and
seroconversion as measured by the hemagglutination inhibition [HI] assay) of an
investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years
of age and older. Subjects will be randomized in a double-blind fashion to receive a single
intramuscular injection of either the investigational vaccine or a licensed egg-derived
seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI
antibody titers on Days 0 and 21, body temperature and injection site reactions will be
monitored daily for 7 days. In addition, subjects will be monitored for adverse events and
rises in body temperature until Day 21 and again until Day 180.
seroconversion as measured by the hemagglutination inhibition [HI] assay) of an
investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years
of age and older. Subjects will be randomized in a double-blind fashion to receive a single
intramuscular injection of either the investigational vaccine or a licensed egg-derived
seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI
antibody titers on Days 0 and 21, body temperature and injection site reactions will be
monitored daily for 7 days. In addition, subjects will be monitored for adverse events and
rises in body temperature until Day 21 and again until Day 180.
Inclusion Criteria:
- Are 50 years of age or older on the day of screening
- Have an understanding of the study, agree to its provisions, have the ability to
adhere to the provisions of the study and give written informed consent prior to
study entry
- If female and capable of bearing children,have a negative urine pregnancy test result
within 24 hours prior to the vaccination on Study Day 0 and agree to employ adequate
birth control measures.
Exclusion Criteria:
- History of severe allergic reaction or anaphylaxis to egg protein or any other
component of the Vero cell-derived influenza vaccine or the egg-derived influenza
vaccine
- Oral temperature of >= 99.5°F (37.5°C) on the day of vaccination in this study (Note:
Subjects meeting this exclusion criterion may be rescheduled for vaccination and
study entry at a later date if certain requirements [in the study protocol] are met)
- Rash or dermatologic condition or tattoos which may interfere with injection site
reaction rating
- Blood transfusion or immunoglobulins received within 90 days of study entry
- Live vaccine received within 4 weeks or inactivated vaccine or subunit vaccine
received within 2 weeks of study entry
- Previous vaccination against influenza for the 2008/2009 northern hemisphere
influenza season
- Functional or surgical asplenia (e.g. from a history of hemoglobinopathies,
leukemias, or lymphomas)
- Diagnosed immunodeficiency as a result of a pathological condition
- Pharmacologically induced immunodeficiency as a result of prescribed administration
of corticosteroids (e.g., any systemic administration of corticosteroids or an
inhaled dose equivalent to 800 mg of beclomethasone dipropionate) or
chemotherapeutics or as a result of radiation therapy or any other modality capable
of altering normal immunologic response
- Known or suspected problem with drug or alcohol abuse
- Investigational drug received within 6 weeks prior to study entry or concurrent
participating in a clinical study that includes the administration of an
investigational product
- Subjects who are a member of the team conducting this study or are in a dependent
relationship with the study investigator. Dependent relationships include close
relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of
the investigator.
We found this trial at
29
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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