D2560C00015 FluMist Annual Safety Study 2018
Completed · Phase 4 · Has a placebo group
Conditions studied: Influenza, Healthy
In brief
This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.
Key facts
- Study ID
- NCT03564444
- Run by
- MedImmune LLC
- People needed
- 300
- Starts
- 2018-06-06
- Expected to finish
- 2018-12-27
- Last updated by the study team
- 2019-12-26
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Research Site — Stockbridge, Georgia, United States
- Research Site — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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