drugset / Trial / NCT01773928
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.
Timeline
- Start
- 2013-01
- Primary completion
- 2013-04
- Completion
- 2013-04
Publications
- Background StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Influenza Virus Vaccine | Vaccine | — | — |
| Comparator | VCIV current | Unknown | — | — |
| Subject | VCIV modified | Vaccine | — | — |