Trials / Completed
CompletedNCT00952705
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age
A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,800 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.
Detailed description
The primary objective of this study was to determine the immunologic noninferiority of MEDI8662, a quadrivalent live attenuated influenza vaccine (Q/LAIV) (delivered intranasally using the blow-fill-seal \[BFS\] delivery system) (Q/LAIV-BFS) to two trivalent formulations of licensed FluMist (delivered intranasally using the Becton Dickinson \[BD\] Accuspray™ device) by comparing the strain-specific geometric mean titers (GMTs) post dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Q/LAIV-BFS (MEDI8662) | A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0. |
| BIOLOGICAL | FluMist/B/Yamagata | FluMist/B/Yamagata - 0.2 mL dose at Day 0 |
| BIOLOGICAL | FluMist/B/Victoria | FluMist/B/Victoria - 0.2 mL dose at Day 0 |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2010-01-01
- Completion
- 2010-03-01
- First posted
- 2009-08-06
- Last updated
- 2018-05-03
- Results posted
- 2012-01-13
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00952705. Inclusion in this directory is not an endorsement.