Study of a Pandemic Influenza Vaccine in Elderly Participants

This study has been completed.
Information provided by:
CSL Limited Identifier:
First received: September 11, 2006
Last updated: November 6, 2008
Last verified: November 2008
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
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:

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00376402

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
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
  More Information

Responsible Party: Dr Russell Basser, CSL Limited 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:
Prevention of Pandemic Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2016