Trials / Completed
CompletedNCT00735475
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine
A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,268 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL Limited Influenza Virus Vaccine (Afluria®) | A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0. |
| BIOLOGICAL | US Licensed Influenza Virus Vaccine (Fluzone®) | A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0. |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-01-01
- Completion
- 2009-06-01
- First posted
- 2008-08-15
- Last updated
- 2018-05-23
- Results posted
- 2011-09-01
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00735475. Inclusion in this directory is not an endorsement.