A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
NCT00945893 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2011-09-12
Summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]
0.5 mL; (intranasal sprayer)
- OTHER
-
Placebo
(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
MedImmune LLC
lead INDUSTRY
Principal Investigators
-
Raburn Mallory, M.D. · MedImmune LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2009-09-30
- Completion
- 2010-03-31
Countries
- United States
Study Locations
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