Trials / Completed
CompletedNCT00946101
A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Children
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 2 Years – 17 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 children.
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 children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] | 0.5 mL: (intranasal sprayer) |
| BIOLOGICAL | Placebo | Placebo was supplied in 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
- 2011-08-11
- Results posted
- 2011-08-11
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00946101. Inclusion in this directory is not an endorsement.