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Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

This study is ongoing, but not recruiting participants.
Study NCT00462215.   Last updated on January 24, 2008.   Information provided by Baxter Healthcare Corporation

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Descriptive Information Fields
Brief Title † Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
Official Title † An Open Label Phase III Study of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine to Assess the Immunogenicity and Safety and to Investigate the Need for and Timing of a Booster Vaccination
Brief Summary

The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.
Detailed Description
Study Phase Phase III
Study Type † Interventional
Study Design † Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † Number of subjects with antibody response to the vaccine strain (A/Vietnam/1203/2004) associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) test >= 20. [ Time Frame: 21 days after the second vaccination (= Day 42 in the study) ] [ Designated as safety issue: No ]
Secondary Outcome Measure †
Condition † Influenza
Intervention † Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Active, not recruiting
Enrollment † 550
Start Date † April 2007
Completion Date June 2009
Eligibility Criteria †

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

  • Are 18 to 59 years of age on the day of screening (for Stratum A only),
  • Are 60 years of age and older on the day of screening (for Stratum B only),
  • Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry,
  • Are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study),
  • Agree to keep a daily record of symptoms,
  • If female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine,
  • Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers),
  • Suffer from or have a history of a significant cardiovascular, pulmonary, neurological, hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder,
  • Are unable to lead an independent life as a result of either physical or mental handicap,
  • Suffer from any kind of immunodeficiency,
  • Suffer from a disease or were undergoing a treatment within 30 days prior to study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs,
  • Have a history of severe allergic reactions or anaphylaxis,
  • Have a rash, 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 donated blood or plasma within 30 days of study entry,
  • Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study,
  • Have a 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, partner/spouse, siblings, parents) as well as employees of the investigator,
  • If female, are pregnant or lactating.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries † Austria,   Germany
Administrative Information Fields
NCT ID † NCT00462215
Organization ID 810601
Secondary IDs ††
Study Sponsor † Baxter Healthcare Corporation
Collaborators ††
Investigators †
Principal Investigator:     Baxter BioScience Investigator, MD     Baxter Healthcare Corporation    
Information Provided By Baxter Healthcare Corporation
Verification Date January 2008
First Received Date † April 17, 2007
Last Updated Date January 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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