Study of a Pandemic Influenza Vaccine

This study has been completed.

First Received on August 26, 2005. Last Updated on November 6, 2008 History of Changes

Sponsor:	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
Influenza	Biological: Pandemic influenza vaccine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Phase Ia Study of a Pandemic Influenza Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

Safety and immunogenicity

Estimated Enrollment:	400
Study Start Date:	October 2005
Estimated Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

History of Guillain-Barre syndrome or active neurological disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136331

Locations

Australia, South Australia
CMAX, a division of IDT Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Terry M Nolan

Murdoch Childrens Research Institute

More Information

No publications provided by CSL Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier:	NCT00136331 History of Changes
Other Study ID Numbers:	CSLCT-PAN-05-12
Study First Received:	August 26, 2005
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 February 09, 2012