Influenza Clinical Trial
Official title:
A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.
Status | Completed |
Enrollment | 400 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Healthy Adults Exclusion Criteria: - Previous vaccination with an influenza Vaccine containing the H5N1 strain - History of clinically significant medical conditions - History of Guillian-Barre Syndrome or active Neurological disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | CMAX, a division of IDT Australia | Adelaide | South Australia |
Australia | Murdoch Childrens Research Institute | Melbourne | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Seqirus |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Immunogenicity | |||
Secondary | Lot to Lot Consistency |
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