Phase II Study of Pandemic Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00320346
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 19, 2016
Information provided by:

May 1, 2006
May 3, 2006
July 19, 2016
July 2006
Not Provided
Safety and Immunogenicity
Same as current
Complete list of historical versions of study NCT00320346 on 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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Dr Russell Basser, CSL Limited
Not Provided
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
November 2008

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