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

History of Changes

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:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

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

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):

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:	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 May 16, 2013

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