Clinical trial NCT00800605: Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
Official title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine to Prevent Culture Confirmed Influenza Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 7252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.


Eligibility criteria: Inclusion Criteria:

* Subject has an understanding of the study
* Subject agrees to study provisions
* Subject gives written informed consent prior to study entry
* Subject is accessible by telephone or electronic mail to receive reminders from the study site
* If female and capable of bearing children, subject has a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agrees to employ adequate birth control measures through the first 60 post-vaccination days.

Exclusion Criteria:

* Subject has any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC, 2008a):

  * Pregnancy
  * Chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)
  * Chronic renal disorders
  * Chronic hepatic disorders
  * Chronic hematological disorders
  * Chronic metabolic disorder (including diabetes mellitus and thyroid disorders)
  * Immunosuppression (including immunosuppression caused by medications, congenital etiologies or HIV)
  * Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)
  * Residence in nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions
  * Household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above
  * Employment as a health care worker
* Subject is unable to lead an independent life as a result of either physical or mental handicap
* Subject has a history of severe allergic reactions or anaphylaxis (e.g., urticaria or asthma that is clinically severe)
* Subject has an oral temperature of \>= 99.5° F (37.5°C) on the day of vaccination in this study. \[NOTE: A subject meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided that certain requirements \[in the study protocol\] are met)
* Subject has a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
* Subject has received a blood transfusion, blood products or immunoglobulins within 90 days of study entry
* Subject has received a live vaccine within 4 weeks or inactivated or subunit vaccine within 2 weeks of study entry
* Subject has previously been vaccinated against influenza for the 2008/2009 northern hemisphere influenza season
* Subject has a functional or surgical asplenia
* Subject has a known or suspected problem with alcohol or drug abuse;
* Subject was administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* Subject is 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: To demonstrate the efficacy of an investigational Vero cell-derived influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine
timeFrame: 21 days
Secondary outcomes:
measure: Rate of subjects with seroconversion at Day 21 after vaccination
timeFrame: 21 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Sacramento
country: United States
facility: Benchmark Research
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: Denver
country: United States
facility: Radiant Research, Inc
state: Colorado
city: Coral Gables
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: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc - Chicago
state: Illinois
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: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
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: Triangle Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research - Cincinnati
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
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: Ft. Worth
country: United States
facility: Benchmark Research Ft. Worth
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research San Angeolo
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research / Westside Medical
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Burke
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:
affiliation: Baxter Healthcare Corporation
name: Baxter Bio Science Investigator, MD
role: STUDY_DIRECTOR
References: