Trials / Completed
CompletedNCT00945893
A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
Detailed description
The primary objective of this study was to assess the safety and descriptive immunogenicity of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in healthy adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2009-09-01
- Completion
- 2010-03-01
- First posted
- 2009-07-24
- Last updated
- 2011-09-12
- Results posted
- 2011-09-05
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00945893. Inclusion in this directory is not an endorsement.