Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800605
• Other study ID #: 720802
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2008
• Last updated: October 7, 2015
• Start date: December 2008
• Est. completion date: June 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7252
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: 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
• Placebo: Phosphate-buffered saline
Single intramuscular injection

Locations

Country	Name	City	State
United States	Benchmark Research Austin	Austin	Texas
United States	PI-COOR Clinical Research	Burke	Virginia
United States	Radiant Research, Inc - Chicago	Chicago	Illinois
United States	Radiant Research - Cincinnati	Cincinnati	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Radiant Research, Inc	Denver	Colorado
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Benchmark Research Ft. Worth	Ft. 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	Benchmark Research	Metairie	Louisiana
United States	Pharmax Research Clinic	Miami	Florida
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	Pembroke Pines	Florida
United States	Triangle Medical Research Associates	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Benchmark Research	Sacramento	California
United States	Jean Brown Research / Westside Medical	Salt Lake City	Utah
United States	Benchmark Research San Angeolo	San Angelo	Texas
United States	California Research Foundation	San Diego	California
United States	Benchmark Research San Francisco	San Francisco	California
United States	Miami Research Associates	South Miami	Florida
United States	Spartanburg Medical Research	Spartanburg	South Carolina
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	Advanced Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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