Influenza Clinical Trial
Official title:
Phase II Study of a Pandemic Influenza Vaccine in Children
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.
Status | Completed |
Enrollment | 220 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 8 Years |
Eligibility |
Inclusion Criteria: - Healthy children aged greater or equal to 6 months to less than 9 years - Normal gestation period Exclusion Criteria: - History of clinically significant medical conditions - History of Guillain 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 | Murdoch Childrens Research Institute | Melbourne | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Seqirus |
Australia,
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---|---|---|---|---|
Primary | Safety and immunogenicity |
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