Back to resultsPhase II Study of Pandemic Influenza Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
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 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
Sites / Locations
- CMAX, a division of IDT Australia
- Murdoch Childrens Research Institute
- Princess Margaret Hospital for Children
Outcomes
Primary Outcome Measures
Safety and Immunogenicity
Secondary Outcome Measures
Lot to Lot Consistency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00320346
Brief Title
Phase II Study of Pandemic Influenza Vaccine
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
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 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.
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
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Pandemic Influenza Vaccine
Primary Outcome Measure Information:
Title
Safety and Immunogenicity
Secondary Outcome Measure Information:
Title
Lot to Lot Consistency
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Country
Australia
Facility Name
Murdoch Childrens Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18599164
Citation
Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.
Results Reference
derived
Learn more about this trial
Phase II Study of Pandemic Influenza Vaccine
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