Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Seqirus |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 1268 |
| Start date | 2008-10 |
| Completion | 2009-06 |
Conditions
- Influenza
Interventions
- CSL Limited Influenza Virus Vaccine (Afluria®)
- US Licensed Influenza Virus Vaccine (Fluzone®)
Primary outcomes
- Geometric Mean Titer 21 Days After the Study Vaccination — 21 days after vaccination
- Percentage of Participants With Seroconversion 21 Days After the Study Vaccination — 21 days after vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Countries
United States