Immune Response Following Seasonal Influenza Vaccination

Inclusion Criteria

• Men and women 18 to 50 years of age, inclusive
• Good general health status, as determined by the Investigator
• Adequate venous access for repeated phlebotomies
• 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)
• Negative drug and alcohol screen at Screening and pre-dose on Day I
• For women of child bearing potential, negative pregnancy test
• 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

• Pregnant, possibly pregnant, or lactating women
• Body mass index> 35.0 kg/m2
• Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
• 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
• History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
• History of coronary artery disease, arrhythmia, or congestive heart failure
• Clinically significant ECG abnormality
• Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or pre-dose on Day I
• History of anaphylaxis or angioedema
• Known allergy to any of the ingredients in the vaccine formulation including egg allergy
• History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
• Previous nasal surgery or nasal cauterization
• Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before Day I
• Significant nasal congestion or rhinorrhea as assessed by the investigator.
• 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
• 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
• Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)
• Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
• Receipt of any IP within 30 days before Day 1
• Receipt of any vaccine within 30 days before Day I
• Receipt of intranasal vaccine within 90 days before Day I
• Receipt of any influenza vaccine within 6 months before Day I
• Any change in medication for a chronic medical condition within 30 days before Day I
• Past regular use or current use of intranasal illicit drugs or any regular u