Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years

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.

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 < 11g/dL for females; <12.5 g/dL for males, white
blood cells (WBC) <2500cell/mm3 or > 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.