h5n1 vaccine study in japanese adults

Conditions: H5N1 Influenza

Summary: the purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an h5n1 pandemic influenza vaccine in a healthy japanese adult population aged 18 to 59 years.


Eligibility criteria:
inclusion criteria: * subject is 18 to 59 years old at the time of screening * subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination * subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary * if female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study exclusion criteria: * subject has a history of infectin with h5n1 virus or a history of vaccination with an h5n1 influenza vaccine * subject is at high risk of contracting h5n1 influenza infection (e.g. poultry workers) * subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including guillain-barré syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder * subject has any inherited or acquired immunodeficiency * subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs * subject has a history of severe allergic reactions or anaphylaxis * subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating * subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry * subject has donated blood or plasma within 30 days prior to study entry * subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study * subject has a functional or surgical asplenia * subject has a known or suspected problem with alcohol or drug abuse * subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product * subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study * if female, subject is pregnant or lactating at the time of enrollment * subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator

Keywords: prophylaxis of influenza infection caused by a pandemic influenza virus (h5n1)