safety and immunogenicity study of an inactivated influenza vaccine (split virus, vero cell derived)

Conditions: Influenza

Summary: the objective of this study is to assess the safety, tolerability and immunogenicity of a split virus, vero cell derived, seasonal influenza vaccine (vciv) in comparison to a licensed egg derived, split virus, seasonal influenza vaccine (eiv) in healthy subjects 18 years of age and older. approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single injection of vciv or eiv. subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine.


Eligibility criteria:
inclusion criteria: male and female subjects who * are 18 to 49 years of age (inclusive) on the day of screening (stratum a) * are 50 years of age or older on the day of screening (stratum b) * 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 administering influenza vaccine outside the scope of a clinical study) * are physically and mentally capable of participating in the study * agree to keep a daily record of symptoms * if female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the vaccination on study day 0 and agree to employ adequate birth control measures. for the purposes of this study adequate birth control measures incorporate 2 types of the following fda approved birth control measures through 60 days after vaccination: * hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, and * an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.) exclusion criteria: subjects who * have previously been vaccinated against influenza with vaccine formulated for the 2006/2007 influenza season * have an oral temperature \>=37.5°c at the time of vaccination on day 0 (see note below) * have type i diabetes * have a body mass index \>35 * have hypertension at screening (with or without medication) that is graded as greater than stage 1 defined as a systolic pressure \>159 or diastolic pressure \>99 while seated and at rest (measurement may be repeated twice before subject is absolutely excluded) * have clinically significant abnormal clinical laboratory values at screening * have clinically significant electrocardiographic abnormalities at screening * test positive for human immunodeficiency virus(hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) * have a history of cardiovascular disease that required hospitalization * have a history of immunodeficiency or autoimmune diseases * have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months * suffer from active neoplastic disease or have a history of hematologic malignancy * 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 (\>800 μg/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, multiple sclerosis) * have received any vaccination within 2 weeks prior to vaccination in this study * have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study * have donated blood or plasma within 30 days prior to vaccination in this study * have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications) * have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating * have a positive urine drug screen (unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation) * were administered an investigational drug within 6 weeks prior to study entry * are concurrently participating in a clinical study that inactivated influenza vaccine (split virus, vero cell derived)includes the administration of an investigational product * are a member of the team conducting this study * 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. note: if all other inclusion/exclusion criteria are met, a subject with a temperature \>=37.5°c on day 0 may be included in the study at a repeat visit provided: 1. they do not have an oral temperature \>=37.5°c at the repeat visit, 2. the repeat visit is no more than 5 calendar days after the initial day 0 visit, 3. the repeat visit is no more than 21 calendar days after all other screening procedures are completed, 4. subjects are still being recruited at the study site.