safety and immunogenicity study of a booster vaccination with a non-adjuvanted h5n1 influenza vaccine (follow up to study 810501)

Conditions: Influenza

Summary: the purpose of this phase ii follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted h5n1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted h5n1 influenza vaccine in a healthy young adult population. a data safety monitoring board will review the safety data after the booster vaccination. the h5n1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.


Eligibility criteria:
inclusion criteria: subjects who participated in study 810501 will be eligible for participation in the study if they: * completed the day 42 visit in study 810501 * 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 * 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 at study entry and agree to employ adequate birth control measures for the duration of the study exclusion criteria: * have a history of vaccination with an h5n1 influenza virus since the second vaccination in study 810501 * have had an allergic reaction to one of the components of the vaccine since the second vaccination in study 810501 * have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in study 810501 * are unable to lead an independent life as a result of either physical or mental handicap * suffer from any kind of immunodeficiency since the second vaccination in study 810501 * suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination 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 had severe allergic reactions or anaphylaxis since the second vaccination in study 810501 * have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating * 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 if female, are pregnant or lactating

Keywords: pandemic influenza