A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2017 |
| Start Date: | August 2009 |
| End Date: | April 2010 |
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for
eliciting an immune response to H1N1 influenza in healthy adults
eliciting an immune response to H1N1 influenza in healthy adults
Inclusion Criteria:
- Male or female aged 18 and older, inclusive, at the time of providing informed
consent.
- Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically
sterile) must be abstinent or be willing to use a medically accepted contraceptive
regimen for the duration of the study. Females of child bearing potential must return
a negative urine pregnancy test result at enrolment and prior to each study
vaccination.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study
Vaccine.
We found this trial at
11
sites
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