Trials / Completed
CompletedNCT00973349
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 2,719 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MF59-eH1N1_f | 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2009-11-01
- Completion
- 2010-12-01
- First posted
- 2009-09-09
- Last updated
- 2015-12-07
- Results posted
- 2011-05-25
Locations
21 sites across 2 countries: United States, Mexico
Source: ClinicalTrials.gov record NCT00973349. Inclusion in this directory is not an endorsement.