Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00566345
First received: November 30, 2007
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.


Condition Intervention Phase
Influenza
Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
Biological: Phosphate buffered saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens [ Time Frame: 21 days to 180 days after the date of vaccination ] [ Designated as safety issue: No ]
  • Consistency of immune response produced by 3 different lots of VCIV [ Time Frame: Through Day 180 after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of occurrence of any injection site reactions and systemic reactions/adverse events related to vaccination [ Time Frame: During the entire 180-day follow-up period ] [ Designated as safety issue: Yes ]

Enrollment: 3670
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vero-cell derived influenza vaccine
Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
Placebo Comparator: 2
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Biological: Phosphate buffered saline
Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female subjects who

  • are 18 to 49 years of age, inclusive, on the day of screening
  • have an understanding of the study, agree to its provisions 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 of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria:

Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):

  • 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)
  • immunosuppression (including immunosuppression caused by medications 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 a 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

Subjects are also excluded if they

  • are unable to lead an independent life as a result of either physical or mental handicap
  • have a history of severe allergic reactions or anaphylaxis
  • have an oral temperature of >= 99.5° F (37.5°C) on the day of vaccination in this study. [NOTE: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided: 1.) oral temperature has decreased to < 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/exclusion criteria are met, 3.) the rescheduled date is no more than 14 days past the initial screening date, 4.) the study site is still enrolling subjects]
  • have a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
  • have received a blood transfusion or immunoglobulins within 90 days of study entry
  • have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of study entry
  • have previously been vaccinated against influenza for the 2007/2008 northern hemisphere influenza season
  • have functional or surgical asplenia
  • have a known or suspected problem with alcohol or drug abuse
  • were 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566345

  Hide Study Locations
Locations
United States, Arizona
Radiant Research Tucson
Tuscon, Arizona, United States, 85710
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Orange County Clinical Research, Inc.
Cypress, California, United States, 90630
Benchmark Research
Sacramento, California, United States, 95816
California Research Foundation
San Diego, California, United States, 92103-6204
Benchmark Research San Francisco
San Francisco, California, United States, 94102
United States, Florida
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Miami Research Associates
Miami, Florida, United States, 33143
University Clinical Research, Inc.
Pembroke, Florida, United States, 33024
United States, Illinois
Radiant Research Inc. - Chicago
Chicago, Illinois, United States, 60610
United States, Kansas
PRA International Clinical Pharmacology Center
Lenexa, Kansas, United States, 66219
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Maryland
Columbia Medical Practice
Columbia, Maryland, United States, 21045
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89130
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Coastal Carolina Research Center
Goose Creek, South Carolina, United States, 29445
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Clinical Research Associates, Inc. - Nashville
Nashville, Tennessee, United States, 37203
United States, Texas
Benchmark Research Austin
Austin, Texas, United States, 78705
Research Across America - CNS Research Group
Dallas, Texas, United States, 75234
Benchmark Research Ft. Worth
Ft. Worth, Texas, United States, 76135
Research Across America - CNS Research Group
Plano, Texas, United States, 75093
Benchmark Research San Angelo
San Angelo, Texas, United States, 76904
Radiant Research - San Antonio Northeast
San Antonio, Texas, United States, 78217
United States, Utah
Jean Brown Associates, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Karen Near, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie McLaren, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00566345     History of Changes
Other Study ID Numbers: 720703
Study First Received: November 30, 2007
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014