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

NCT ID: NCT00800605

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 7250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Vero cell-derived, trivalent, seasonal influenza vaccine

Group Type: EXPERIMENTAL

Vero cell-derived, trivalent, seasonal influenza vaccine

Intervention Type: BIOLOGICAL

Single intramuscular injection

2

Phosphate-buffered saline

Group Type: PLACEBO_COMPARATOR

Placebo: Phosphate-buffered saline

Intervention Type: BIOLOGICAL

Single intramuscular injection

Interventions

Vero cell-derived, trivalent, seasonal influenza vaccine

Single intramuscular injection

Intervention Type: BIOLOGICAL

Placebo: Phosphate-buffered saline

Single intramuscular injection

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baxter Bio Science Investigator, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States

Benchmark Research

Sacramento, California, United States

California Research Foundation

San Diego, California, United States

Benchmark Research San Francisco

San Francisco, California, United States

Radiant Research, Inc

Denver, Colorado, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Pharmax Research Clinic

Miami, Florida, United States

University Clinical Research, Inc

Pembroke Pines, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Radiant Research, Inc - Chicago

Chicago, Illinois, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

Benchmark Research

Metairie, Louisiana, United States

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Radiant Research, Inc.

St Louis, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Regional Clinical Research, Inc.

Endwell, New York, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

Triangle Medical Research Associates

Raleigh, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Radiant Research - Cincinnati

Cincinnati, Ohio, United States

Omega Medical Research

Warwick, Rhode Island, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Clinical Research Associates, Inc. - Nashville

Nashville, Tennessee, United States

Benchmark Research Austin

Austin, Texas, United States

Benchmark Research Ft. Worth

Fort Worth, Texas, United States

Benchmark Research San Angeolo

San Angelo, Texas, United States

Jean Brown Research / Westside Medical

Salt Lake City, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

PI-COOR Clinical Research

Burke, Virginia, United States

Clinical Research Associates of Tidewater

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

720802

Identifier Type: -

Identifier Source: org_study_id