Study of a Pandemic Influenza Vaccine in Elderly Participants

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00376402
• Lead Sponsor: Seqirus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Study Start: 2006-10
• Study Completion: 2007-06
• Status Verified: 2008-11
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and immunogenicity

Trial Locations

Locations (2)

Princess Margaret Hospital for Children; 🇦🇺 Perth, Western Australia, Australia

CMAX, a division of IDT Australia; 🇦🇺 Adelaide, South Australia, Australia