Back to resultsStudy of a Pandemic Influenza Vaccine in Elderly Participants
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
H5N1 Pandemic Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
Eligibility Criteria
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
Sites / Locations
- CMAX, a division of IDT Australia
- Princess Margaret Hospital for Children
Outcomes
Primary Outcome Measures
Safety and immunogenicity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00376402
Brief Title
Study of a Pandemic Influenza Vaccine in Elderly Participants
Official Title
Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Seqirus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
H5N1 Pandemic Influenza Vaccine
Primary Outcome Measure Information:
Title
Safety and immunogenicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Richmond, Dr
Organizational Affiliation
Princess Margaret Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMAX, a division of IDT Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6840
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study of a Pandemic Influenza Vaccine in Elderly Participants
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