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Study of a Pandemic Influenza Vaccine in Elderly Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376402
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : July 19, 2016
Sponsor:
Information provided by:
Seqirus

Study Description
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Brief Summary:
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.

Condition or disease Intervention/treatment Phase
Influenza Biological: H5N1 Pandemic Influenza Vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants
Study Start Date : October 2006
Study Completion Date : June 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and immunogenicity

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female participants

Exclusion Criteria:

  • History of clinically significant medical conditions
  • History of Guillain-Barre syndrome or active neurological disease
  • Resident of nursing home or long-term care facility
Contacts and Locations
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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): NCT00376402


Locations
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Australia, South Australia
CMAX, a division of IDT Australia
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6840
Sponsors and Collaborators
Seqirus
Investigators
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Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
More Information
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Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00376402    
Other Study ID Numbers: CSLCT-PAN-05-24
First Posted: September 14, 2006    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