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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00370864
Registration number
NCT00370864
Ethics application status
Date submitted
30/08/2006
Date registered
1/09/2006
Date last updated
19/07/2016
Titles & IDs
Public title
Study of a Pandemic Influenza Vaccine in Children
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Scientific title
Phase II Study of a Pandemic Influenza Vaccine in Children
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Secondary ID [1]
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CSLCT-PAN-05-17
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - H5N1 pandemic influenza vaccine
Other interventions: H5N1 pandemic influenza vaccine
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and immunogenicity
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Healthy children aged greater or equal to 6 months to less than 9 years
- Normal gestation period
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Minimum age
6
Months
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History of clinically significant medical conditions
- History of Guillain Barre syndrome or active neurological disease
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2007
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Murdoch Childrens Research Institute - Melbourne
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment postcode(s) [2]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Seqirus
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00370864
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Terry M Nolan, Prof
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Address
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Murdoch Childrens Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00370864
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