Status:
COMPLETED
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
6-9 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
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 gestation.
Exclusion
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, 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 :
473 Patients enrolled
Trial Details
Trial ID
NCT00958243
Start Date
August 1 2009
End Date
April 1 2010
Last Update
May 23 2018
Active Locations (13)
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1
Chandler, Arizona, United States, 85224
2
Melbourne, Florida, United States, 32935
3
Bardstown, Kentucky, United States, 40004
4
Metairie, Louisiana, United States, 70006