Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782431
• Other study ID #: 720801
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2008
• Last updated: October 7, 2015
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3195
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Vero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
• Licensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection

Locations

Country	Name	City	State
United States	Benchmark Research Austin	Austin	Texas
United States	Clinical Research of South Florida	Coral Cables	Florida
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Pi-Coor Clinical Research	Fairfax	Virginia
United States	Benchmark Research Ft. Worth	Fort Worth	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Palmetto Medical Research	Mt. Pleasant	South Carolina
United States	Clinical Research Associates, Inc. - Nashville	Nashville	Tennessee
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	University Clinical Research, Inc.	Pembrook Pines	Florida
United States	Research Across America	Plano	Texas
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rochester Clinical Research Inc.	Rochester	New York
United States	Benchmark Research, San Francisco	Sacramento	California
United States	Benchmark Research San Angelo	San Angelo	Texas
United States	California Research Foundation	San Diego	California
United States	Benchmark Research San Francisco	San Francisco	California
United States	Radiant Research, Inc.	St. Louis	Missouri
United States	Sundance Clinical Research	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Heartland Research Associates LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion at Day 21 after vaccination		21 days	No
Secondary	Rate of subjects with seroconversion at Day 21 after vaccination		21 days	No