Study of a Pandemic Influenza Vaccine in Children

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.

Official Title

Phase II Study of a Pandemic Influenza Vaccine in Children

Conditions

• Influenza

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcomes: Safety and immunogenicity

Study Start

September 2006; Expected completion: June 2007

Eligibility & Criteria

• Ages Eligible for Study: 6 Months – 8 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers

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

Total Enrolment

220

Contact Details

Murdoch Childrens Research Institute Melbourne, Victoria, 3052, Australia; Recruiting

• Terry M Nolan, Prof +61 3 9344 9350