Study of a Pandemic Influenza Vaccine in Children

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00370864
• Lead Sponsor: Seqirus

Brief Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-31
• Study Start: 2006-09
• Study First Posted: 2006-09-01
• Study Completion: 2007-07
• Status Verified: 2008-11
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Healthy children aged greater or equal to 6 months to less than 9 years
• Normal gestation period

Exclusion Criteria

• History of clinically significant medical conditions
• History of Guillain Barre syndrome or active neurological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and immunogenicity

Trial Locations

Locations (2)

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

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