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Safety of Monovalent FluMist Vaccine in Healthy Adults
NCT00480155Phase 2
Key facts
- Status
- Completed
- Start
- May 2007
- Primary completion
- Dec 2007
- Countries
- 1
- Sponsor
- MedImmune
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- influenza vaccine (trivalent, inactivated) or influenza vaccine (live, attenuated, intranasal)
- Conditions
- influenza
01
Overview
Phase 2, randomised, double-blind trial of influenza vaccine (trivalent, inactivated) or influenza vaccine (live, attenuated, intranasal) in influenza (2 arms), sponsored by MedImmune. Primary endpoint: Fever >= 101 F at 7 days. Started May 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
FluMist
Monovalent Frozen FluMist intranasal spray
Placebo
Placebo intranasal spray
03
Who it enrols
Healthy adults 18-49 years old without chronic conditions, immune deficiency, or recent acute illness.
04
Endpoints
Primary
Fever >= 101 F
Secondary
Secondary outcome measures (SEs and AEs)
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