NCT00376402CompletedPhase 2
Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants
Seqirus4 sites in 1 country200 target enrollmentStarted: October 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Safety and immunogenicity
Study Overview
Brief Summary
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female participants
Exclusion Criteria
- •History of clinically significant medical conditions
- •History of Guillain-Barre syndrome or active neurological disease
- •Resident of nursing home or long-term care facility
Outcomes
Primary Outcomes
Safety and immunogenicity
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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