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
  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 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 Intervention Phase
Influenza
Biological: Pandemic Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:


Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Safety and Immunogenicity

Secondary Outcome Measures:
  • Lot to Lot Consistency

Estimated Enrollment: 400
Study Start Date: July 2006
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320346

Locations
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
CSL Limited
Investigators
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
  More Information

No publications provided by CSL Limited

Additional 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
Study First Received: May 1, 2006
Last Updated: November 6, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:
Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014