Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Completed · Phase 4 · Has a placebo group
Conditions studied: Influenza, Healthy
In brief
This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza season.
Key facts
- Study ID
- NCT01859143
- Run by
- MedImmune LLC
- People needed
- 300
- Starts
- 2013-05-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-11-10
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), 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
Where it is running
- Research Site — Miami, Florida, United States
- Research Site — Stockbridge, Georgia, United States
- Research Site — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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