D2560C00015 FluMist Annual Safety Study 2018

This prospective. randomized, double-blind. placebo-controlled release study will enroll
approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday).
Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of
bivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.
This study will be conducted at 2 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), renaldysfunction, 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 to randomization

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

- History of Guillain-Barre syndrome.