Status:
COMPLETED
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
1313 Patients enrolled
Trial Details
Trial ID
NCT00958126
Start Date
August 1 2009
End Date
April 1 2010
Last Update
November 21 2017
Active Locations (11)
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1
Study Site
Huntsville, Alabama, United States, 35802
2
Study Site
San Diego, California, United States, 92108
3
Study Site
Melbourne, Florida, United States, 32935
4
Study Site
Peoria, Illinois, United States, 61602