Influenza
Conditions
Brief summary
To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
Detailed description
The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.
Interventions
BIOLOGICALAV024
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
OTHERPlacebo
Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-64 years of age (not yet reached their 65th birthday); * In good health; * Available by telephone; * Ability to understand and comply with the requirements of the protocol; and * Signed informed consent.
Exclusion criteria
* Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year; * Acute febrile (\>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment; * Hypersensitivity to egg or egg protein; * Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household; * Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and * Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The primary endpoint of this study is fever defined as oral temperature ≥101°F | Days 0-7 |
Secondary
| Measure | Time frame |
|---|---|
| All other reported reactogenicity events and other adverse events. | After 7 days after vaccination |
Countries
United States
Outcome results
None listed