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Study of a Pandemic Influenza Vaccine in Elderly Participants

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00376402
First received: September 11, 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 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 Intervention Phase
Influenza
 Biological: H5N1 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: Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Safety and immunogenicity

Estimated Enrollment: 200
Study Start Date: October 2006
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376402

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

No publications provided

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00376402     History of Changes
Other Study ID Numbers: CSLCT-PAN-05-24
Study First Received: September 11, 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 19, 2013