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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00376402
Other study ID # CSLCT-PAN-05-24
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2006
Last updated July 17, 2016
Start date October 2006
Est. completion date June 2007

Study information

Verified date November 2008
Source Seqirus
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
H5N1 Pandemic Influenza Vaccine


Locations

Country Name City State
Australia CMAX, a division of IDT Australia Adelaide South Australia
Australia Princess Margaret Hospital for Children Perth Western Australia

Sponsors (1)

Lead Sponsor Collaborator
Seqirus

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and immunogenicity
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