Phase II Study of Pandemic Influenza Vaccine

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00320346
• Lead Sponsor: Seqirus

Brief Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Study Start: 2006-07
• Study Completion: 2006-09
• Status Verified: 2008-11
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Healthy Adults

Exclusion Criteria

• Previous vaccination with an influenza Vaccine containing the H5N1 strain
• History of clinically significant medical conditions
• History of Guillian-Barre Syndrome or active Neurological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and Immunogenicity

Secondary Outcome Measures

Name	Time	Method
Lot to Lot Consistency

Trial Locations

Locations (3)

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

Murdoch Childrens Research Institute; 🇦🇺 Melbourne, Victoria, Australia

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