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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00782431
First received: October 30, 2008
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Vero cell derived, trivalent, seasonal influenza vaccine
Biological: Licensed egg-derived, trivalent seasonal influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Seroconversion at Day 21 after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of subjects with seroconversion at Day 21 after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 3195
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vero cell-derived, trivalent, seasonal influenza vaccine
Biological: Vero cell derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
Active Comparator: 2
Licensed egg-derived, trivalent seasonal influenza vaccine
Biological: Licensed egg-derived, trivalent seasonal influenza vaccine
Single intramuscular injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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 if certain requirements [in the study protocol] are met)
  • 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.
  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: NCT00782431

  Show 30 Study Locations
Sponsors and Collaborators
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: Karen Near, MD; Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00782431     History of Changes
Other Study ID Numbers: 720801
Study First Received: October 30, 2008
Last Updated: October 29, 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 September 16, 2014