Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
Summary
The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.
Timeline
- Start
- 2006-06
- Primary completion
- 2006-08
- Completion
- 2006-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free | Vaccine | 0.5 ml | — |
| Subject | CSL Trivalent Inactivated Influenza Vaccine with Thimerosal | Vaccine | 0.5 ml | — |