To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
330
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
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).
SFBC International Inc
Miami, Florida, United States
- The primary endpoint of this study is fever defined as oral temperature ≥101°F
Time frame: Days 0-7
All other reported reactogenicity events and other adverse events.
Time frame: After 7 days after vaccination
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