Clinical trial NCT00782431: Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 3195
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion at Day 21 after vaccination
timeFrame: 21 days
Secondary outcomes:
measure: Rate of subjects with seroconversion at Day 21 after vaccination
timeFrame: 21 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Sacramento
country: United States
facility: Benchmark Research, San Francisco
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Francisco
country: United States
facility: Benchmark Research San Francisco
state: California
city: Coral Cables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pembrook Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc. - Nashville
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research Austin
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research Ft. Worth
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research San Angelo
state: Texas
city: Fairfax
country: United States
facility: Pi-Coor Clinical Research
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
References:
citation: Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.