Phase II Study of Pandemic Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00320346
First received: May 1, 2006
Last updated: November 6, 2008
Last verified: November 2008

May 1, 2006
November 6, 2008
July 2006
Not Provided
Safety and Immunogenicity
Same as current
Complete list of historical versions of study NCT00320346 on ClinicalTrials.gov Archive Site
Lot to Lot Consistency
Same as current
Not Provided
Not Provided
 
Phase II Study of Pandemic Influenza Vaccine
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).

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Influenza
Biological: Pandemic Influenza Vaccine
Not Provided
Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Höschler 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. Epub 2008 Jun 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2006
Not Provided

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00320346
CSLCT-PAN-05-18
Not Provided
Dr Russell Basser, CSL Limited
CSL Limited
Not Provided
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
CSL Limited
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP