Trials / Completed
CompletedNCT00562484
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 7,500 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL Limited Influenza Vaccine | A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0. |
| BIOLOGICAL | Placebo | Placebo |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-11-01
- Completion
- 2010-01-01
- First posted
- 2007-11-22
- Last updated
- 2017-11-21
- Results posted
- 2011-09-12
Locations
24 sites across 2 countries: Australia, New Zealand
Source: ClinicalTrials.gov record NCT00562484. Inclusion in this directory is not an endorsement.