Immune Response Following Seasonal Influenza Vaccination

Subjects will be screened within 28 days prior to enrollment into the study. After qualifying
for the study subjects will visit the clinical unit on Day l and will have pre-dose blood
samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs)
immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then
be given the vaccine.

Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and
181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess
cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments
will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and
alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.

Adverse events (AEs) will be monitored throughout the study.

Inclusion Criteria:

1. Men and women 18 to 50 years of age, inclusive

2. Good general health status, as determined by the Investigator

3. Adequate venous access for repeated phlebotomies

4. Screening laboratory results within institutional normal range or Grade 1 elevation if
the Investigator documents clinical insignificance. Bilirubin may be Grade 2 if
associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) and the Investigator considers the result not to be clinically significant (e.g.
vigorous exercise or Gilbert's syndrome)

5. Negative drug and alcohol screen at Screening and pre-dose on Day I

6. For women of child bearing potential, negative pregnancy test

7. Willingness to practice a highly effective method of contraception that may include,
but is not limited to, abstinence, sex only with persons of the same sex,monogamous
relationship with a postmenopausal partner, monogamous relationship with vasectomized
partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation,
salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD),
or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28
days after the Fluzone Intramuscular Quadrivalent vaccine dose.

Exclusion Criteria:

1. Pregnant, possibly pregnant, or lactating women

2. Body mass index> 35.0 kg/m2

3. Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening

4. Asthma or other chronic lung disease that is greater than mild in severity.
Specifically excluded are participants with any of the following events in the past
year:

- Daily symptoms

- Daily use of short acting beta 2 agonists

- Use of inhaled steroids or theophylline

- Use of pulse systemic steroids

- Emergency care or hospitalization related to asthma or other chronic lung disease

- Systemic steroids for asthma exacerbation

5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not
required postpartum and serum glucose is currently in the normal range)

6. History of coronary artery disease, arrhythmia, or congestive heart failure

7. Clinically significant ECG abnormality

8. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood
pressure > 95 mmHg) at Screening or pre-dose on Day I

9. History of anaphylaxis or angioedema

10. Known allergy to any of the ingredients in the vaccine formulation including egg
allergy

11. History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other
nasal abnormality that might affect vaccine administration

12. Previous nasal surgery or nasal cauterization

13. Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before
Day I

14. Significant nasal congestion or rhinorrhea as assessed by the investigator.

15. Known or suspected malignancy, excluding non-melanoma skin cancers and other early
stage surgically excised malignancies that the Investigator considers to be
exceedingly unlikely to recur

16. Immunocompromised individuals, including those who have used corticosteroids
(including intranasal steroids), alkylating drugs, antimetabolites, radiation,
immune-modulating biologics, or other immunomodulating therapies within 90 days before
Day 1 or those who plan use during the study period

17. Use of statin medication within 30 days before Day I (including atorvastatin,
fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)

18. Receipt of intranasal medications (including over-the-counter medications) within 30
days before Day 1

19. Receipt of any IP within 30 days before Day 1

20. Receipt of any vaccine within 30 days before Day I

21. Receipt of intranasal vaccine within 90 days before Day I

22. Receipt of any influenza vaccine within 6 months before Day I

23. Any change in medication for a chronic medical condition within 30 days before Day I

24. Past regular use or current use of intranasal illicit drugs or any regular use of
illicit drugs by any other route.

25. Use of tobacco products or electronic cigarettes within 30 days before Day l. Any
other smoking products including marijuana will be excluded.

26. Any medical, psychiatric, or social condition or any occupational or other
responsibility that in the judgment of the Investigator would interfere with or serve
as a contraindication to protocol adherence, assessment of safety (including
immunogenicity), or a subject's ability to give informed consent