- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136331
Study of a Pandemic Influenza Vaccine
July 17, 2016 updated by: Seqirus
Phase Ia Study of a Pandemic Influenza Vaccine
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 avian influenza pandemic.
This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
400
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
- CMAX, a division of IDT Australia
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Victoria
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Melbourne, Victoria, Australia, 3052
- Murdoch Childrens Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- History of Guillain-Barre syndrome or active neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and immunogenicity
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terry M Nolan, Murdoch Childrens Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 29, 2005
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 17, 2016
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSLCT-PAN-05-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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