Status:
COMPLETED
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Lead Sponsor:
Seqirus
Conditions:
Influenza Caused by the Novel Influenza A (H1N1) Virus
Eligibility:
All Genders
6-8 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 children.
Eligibility Criteria
Inclusion
- Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination.
- For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.
Exclusion
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, 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 :
370 Patients enrolled
Trial Details
Trial ID
NCT00940108
Start Date
August 1 2009
End Date
April 1 2010
Last Update
June 28 2018
Active Locations (5)
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1
Study Site
Westmead, New South Wales, Australia, 2145
2
Study Site
Brisbane, Queensland, Australia, 4006
3
Study Site
North Adelaide, South Australia, Australia, 5006
4
Study Site
Carlton, Victoria, Australia, 3010