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

This is an interventional prevention trial for Influenza focused on measuring Pandemic influenza Read More

Inclusion Criteria:

• Are 21 to 45 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
• Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
• Are physically and mentally capable of participating in the study
• Agree to keep a daily record of symptoms for the duration of the study
• If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

• Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
• Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
• Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
• Suffer from any inherited or acquired immunodeficiency
• Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
• Suffer from a disease or are 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 inflammatory or degenerative neurological disease (e.g. Guillain Barré syndrome)
• 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 undergone systemic corticoid therapy within 30 days prior to study entry
• 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 or site conducting the study
• If female: are pregnant or lactating