Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Vero cell derived, trivalent, seasonal influenza vaccine Biological: Licensed egg-derived, trivalent seasonal influenza vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
- Seroconversion at Day 21 after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Rate of subjects with seroconversion at Day 21 after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3195 |
| Study Start Date: | November 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Vero cell-derived, trivalent, seasonal influenza vaccine
|
Biological: Vero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
|
|
Active Comparator: 2
Licensed egg-derived, trivalent seasonal influenza vaccine
|
Biological: Licensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
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More Information
No publications provided by Baxter Healthcare Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Karen Near, MD; Medical Director, Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00782431 History of Changes |
| Other Study ID Numbers: | 720801 |
| Study First Received: | October 30, 2008 |
| Last Updated: | October 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013