Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2018-06-06
2018-12-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Bivalent influenza vaccine
A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1
Bivalent influenza vaccine
A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.
Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Interventions
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Bivalent influenza vaccine
A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.
Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Segall, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Atlanta
Keith Klatt, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia Research Group
Locations
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Research Site
Stockbridge, Georgia, United States
Research Site
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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D2560C00015
Identifier Type: -
Identifier Source: org_study_id