Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

NCT00782431 | Completed Phase 3 Results DMC

• 1 other identifier: 720801
• Study Type: interventional
• Target: 3,208
• Locations: 1 country
• Sites: 30

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Seroconversion Antibody Titer

  The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer \< 10) at baseline.

  21 days

• Percentage of Subjects With Seroprotective Antibody Titer

  The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.

  21 days

Secondary Outcomes (5)

• Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination

  21 days

• Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline

  21 days

• Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination

  21 days

• Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination

  21 days

• Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period

  180 days

Study Arms (2)

1

EXPERIMENTAL

Vero cell-derived, trivalent, seasonal influenza vaccine

Biological: Vero cell derived, trivalent, seasonal influenza vaccine

2

ACTIVE COMPARATOR

Licensed egg-derived, trivalent seasonal influenza vaccine

Biological: Licensed egg-derived, trivalent seasonal influenza vaccine

Interventions

Vero cell derived, trivalent, seasonal influenza vaccine BIOLOGICAL

Single intramuscular injection

1

Licensed egg-derived, trivalent seasonal influenza vaccine BIOLOGICAL

Single intramuscular injection

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (30)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, 85712, United States

Location

Benchmark Research, San Francisco

Sacramento, California, 95816, United States

Location

California Research Foundation

San Diego, California, 92103-6204, United States

Location

Benchmark Research San Francisco

San Francisco, California, 94102, 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

University Clinical Research, Inc.

Pembroke Pines, Florida, 33024, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, 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

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates LLC

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, 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

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, 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

Research Across America

Plano, Texas, 75093, United States

Location

Benchmark Research San Angelo

San Angelo, Texas, 76904, United States

Location

Pi-Coor Clinical Research

Fairfax, Virginia, 22030, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 22172502 DERIVED

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

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: October 30, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2009
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Locations

US (30)