study of the immunogenicity and safety of a quadrivalent influenza vaccine (vax2012q) in adults 18-64 years

Conditions: Influenza

Summary: this is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of vax2012q or a licensed quadrivalent influenza vaccine. the subjects will be randomized at a 1:1:1 ratio.

this is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either vax2012q or fluzone. four hundred fifty (450) subjects will be randomized 1:1:1 ratio of either 8 or 12 mcg vax2012q dose levels or to fluzone® quadrivalent vaccine. randomization will be stratified for age (18-49 and 50-64 years). subjects will be stratified by two age groups (18-49 and 50-64) and randomized in a 1:1:1 ratio to either 8 or 12 mcg vax2012q dose levels or to fluzone® quadrivalent vaccine. 25-35% of the total study population will be recruited into the 50-64 age group. the primary objective of the study is to evaluate the seroconversion rates at day 21 for both dose levels of vax2012q.

Eligibility criteria:
inclusion criteria: * males and females, 18-64 years of age. * females must be: 1. surgically sterilized 2. post menopausal: * 12 months of spontaneous amenorrhea or * 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (fsh) levels \> 40 milli-international units (miu)/ml or * 6 weeks postsurgical bilateral oophorectomy 3. those of childbearing potential must have a negative pre-treatment serum pregnancy test followed by a confirmatory urine pregnancy test immediately prior to vaccination and must agree to use a reliable form of contraception for at least 21 days post vaccination including contraceptives, intrauterine device, double-barrier method. * in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the principal investigator. * must sign informed consent indicating understanding of the purpose of and procedures required for the study and willingness to participate. exclusion criteria: * within 6 months preceding the administration of the study vaccine, receiving any licensed or investigational vaccine. * within 30 days preceding the administration of the study vaccine, receiving any investigational drug. * excessive chronic alcohol use within the last 5 years. * history of drug abuse, other than recreational cannabis use, within the last 5 years that could affect the subject's participation in the study. * significant psychiatric illness within the last 12 months which would interfere with the study. * a chronic illness that is not medically stable, receiving a concomitant therapy in which the medication dose has not been stable for at least 3 months prior to immunization or has any other condition that could interfere with the study. * clinically significant abnormal liver function tests at screening: alanine transaminase (alt) or aspartate aminotransferase (ast) \>2.5 upper limit of normal (uln). * total bilirubin \> 1.5 uln if alt or ast \> uln or total bilirubin \> 2 uln with alt and ast within normal range . * creatinine \>1.7mg/dl, hemoglobin \ 15,000cell/mm3, platelet count \<125,000cell/mm3 * positive serology for hbsag, hepatitis c virus (hcv) or hiv * have cancer or have received treatment for cancer within three years, excluding in situ cervical carcinoma or basal /squamous cell carcinoma of the skin at other than the vaccination site. * any autoimmune disease. * presently receiving or having a recent history of receiving (≤ six months) any medication or therapeutic modality that affects the immune system or a drug known to be frequently associated with significant major organ toxicity or system corticosteroids (oral or injectable). * history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component. * allergic to egg or egg products. * history of guillain-barré syndrome. * receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination * donation of blood or blood products within 4 weeks prior to vaccination or during the 4 week study period following vaccination. * acute disease within 72 hours prior to vaccination. * an oral temperature \>100.4°f (38°c) on the day of vaccination * body mass index \>40. * known bleeding disorders or receiving prescribed oral or parenteral anticoagulants. * any other condition or circumstance which, in the opinion of the principal investigator, poses an unacceptable risk for participation in the study or could interfere with study evaluations.