Clinical Trial: Phase Ia Study of a Pandemic Influenza Vaccine

This study is not yet open for patient recruitment.
Verified by CSL Limited August 2005

Sponsored by: CSL Limited
Information provided by: CSL Limited
ClinicalTrials.gov Identifier: NCT00136331

Purpose

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.
Condition Intervention Phase
Prevention of Pandemic Influenza
 Vaccine: Pandemic Influenza Vaccine
Phase I

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Safety and immunogenicity
Secondary Outcomes: Nil
Expected Total Enrollment:  400

Study start: October 2005;  Expected completion: January 2007
Last follow-up: November 2006;  Data entry closure: January 2007

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy Adults

Exclusion Criteria:

  • History of Guillain-Barre Syndrome or active Neurological disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136331


Australia, South Australia
      CMAX, a division of IDT Australia, Adelaide,  South Australia,  5000,  Australia
Dr Kelly Papanaoum  +61 8 8222 4000 
Dr Kelly Papanaoum,  Principal Investigator

Australia, Victoria
      Murdoch Childrens Research Institute, Melbourne,  Victoria,  3052,  Australia
Professor Terry Nolan
Professor Terry M Nolan,  Principal Investigator

Study chairs or principal investigators

Terry M Nolan,  Principal Investigator,  Murdoch Childrens Research Institute   

More Information

Study ID Numbers:  CSLCT-PAN-05-12
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00136331
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-08-30

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