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

NCT00800605 | Completed Phase 3 Results DMC

• 1 other identifier: 720802
• Study Type: interventional
• Target: 7,250
• Locations: 1 country
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• 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

  The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.

  180 days

Secondary Outcomes (9)

• Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine

  180 days

• Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically

  180 days

• HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21

  21 days

• Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21

  21 days

• Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline

  21 days

Study Arms (2)

1

EXPERIMENTAL

Vero cell-derived, trivalent, seasonal influenza vaccine

Biological: Vero cell-derived, trivalent, seasonal influenza vaccine

2

PLACEBO COMPARATOR

Phosphate-buffered saline

Biological: Placebo: Phosphate-buffered saline

Interventions

Vero cell-derived, trivalent, seasonal influenza vaccine BIOLOGICAL

Single intramuscular injection

1

Placebo: Phosphate-buffered saline BIOLOGICAL

Single intramuscular injection

2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (36)

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, 85712, United States

Location

Benchmark Research

Sacramento, California, 95816, United States

Location

California Research Foundation

San Diego, California, 92103, United States

Location

Benchmark Research San Francisco

San Francisco, California, 94102, United States

Location

Radiant Research, Inc

Denver, Colorado, 80239, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

University Clinical Research, Inc

Pembroke Pines, Florida, 33024, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Radiant Research, Inc - Chicago

Chicago, Illinois, 60654, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Radiant Research, Inc.

St Louis, Missouri, 63141, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Triangle Medical Research Associates

Raleigh, North Carolina, 27609, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Radiant Research - Cincinnati

Cincinnati, Ohio, 45249, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Clinical Research Associates, Inc. - Nashville

Nashville, Tennessee, 37203, United States

Location

Benchmark Research Austin

Austin, Texas, 78705, United States

Location

Benchmark Research Ft. Worth

Fort Worth, Texas, 76135, United States

Location

Benchmark Research San Angeolo

San Angelo, Texas, 76904, United States

Location

Jean Brown Research / Westside Medical

Salt Lake City, Utah, 84124, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

PI-COOR Clinical Research

Burke, Virginia, 22015, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Angie Kimbler
• Organization: Alachua Government Services, Inc.

angie.kimbler@resilience.com

386-418-8751

Study Officials

• Baxter Bio Science Investigator, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Locations

US (36)