Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season

This prospective, randomized, double-blind, placebo-controlled release study will enroll
approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly
assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by
intranasal spray. Randomization will be stratified by site. This study will be conducted at
3 sites in the United States of America. Each subject will receive 1 dose of investigational
product on Day 1. The duration of study participation for each subject is the time from
study vaccination through 180 days after study vaccination.

Inclusion Criteria:

- Age 18 through 49 years

- Written informed consent

- Subject available by telephone

- Ability to understand and comply with the requirements of the protocol, as judged by
the Investigator

Exclusion Criteria:

- Concurrent enrollment in another clinical study up to 180 days after receipt of
investigational product (Day 181)

- History of hypersensitivity to any component of the vaccine, including egg or egg
protein or serious, life threatening, or severe reactions to previous influenza
vaccinations

- Any condition for which the inactivated influenza vaccine is indicated, including
chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma),
chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or
hemoglobinopathies that required regular medical follow-up or hospitalization during
the preceding year

- Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent)
and/or clinically significant respiratory illness (example, cough or sore throat)
within 14 days prior to randomization

- Any known immunosuppressive condition or immune deficiency disease, including human
immunodeficiency virus infection, or ongoing immunosuppressive therapy

- History of Guillain-Barré syndrome