Study of a Pandemic Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT00136331

Recruitment Status : Completed

First Posted : August 29, 2005

Last Update Posted : July 19, 2016

Sponsor:

Information provided by:

Seqirus

Study Description

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 avian influenza pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Pandemic influenza vaccine	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Prevention
Official Title:	Phase Ia Study of a Pandemic Influenza Vaccine
Study Start Date :	October 2005
Study Completion Date :	November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Safety and immunogenicity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

History of Guillain-Barre syndrome or active neurological disease

Contacts and Locations

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): NCT00136331

Locations

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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

Seqirus

Investigators

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Principal Investigator:	Terry M Nolan	Murdoch Childrens Research Institute

More Information

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. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.

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Responsible Party:	Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier:	NCT00136331
Other Study ID Numbers:	CSLCT-PAN-05-12
First Posted:	August 29, 2005 Key Record Dates
Last Update Posted:	July 19, 2016
Last Verified:	November 2008

Keywords provided by Seqirus:


Pandemic Influenza Prevention Vaccine Prevention of Pandemic Influenza

Additional relevant MeSH terms:

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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections	Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases

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