Back to resultsStudy of a Pandemic Influenza Vaccine in Children
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
H5N1 pandemic influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
Eligibility Criteria
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
Sites / Locations
- Murdoch Childrens Research Institute
- Princess Margaret Hospital for Children
Outcomes
Primary Outcome Measures
Safety and immunogenicity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00370864
Brief Title
Study of a Pandemic Influenza Vaccine in Children
Official Title
Phase II Study of a Pandemic Influenza Vaccine in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seqirus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
H5N1 pandemic influenza vaccine
Primary Outcome Measure Information:
Title
Safety and immunogenicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry M Nolan, Prof
Organizational Affiliation
Murdoch Childrens Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Murdoch Childrens Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18801398
Citation
Nolan T, Richmond PC, Formica NT, Hoschler K, Skeljo MV, Stoney T, McVernon J, Hartel G, Sawlwin DC, Bennet J, Ryan D, Basser RL, Zambon MC. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine. 2008 Nov 25;26(50):6383-91. doi: 10.1016/j.vaccine.2008.08.046. Epub 2008 Sep 16.
Results Reference
derived
Learn more about this trial
Study of a Pandemic Influenza Vaccine in Children
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