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Phase II Study of Pandemic Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT00320346
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 19, 2016
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Pandemic Influenza Vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : July 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety and Immunogenicity

Secondary Outcome Measures :
  1. Lot to Lot Consistency

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320346

Australia, South Australia
CMAX, a division of IDT Australia
Adelaide, South Australia, Australia
Australia, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Sponsors and Collaborators
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00320346     History of Changes
Other Study ID Numbers: CSLCT-PAN-05-18
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: November 2008

Keywords provided by Seqirus:
Prevention of Pandemic Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs