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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase II Study of a Pandemic Influenza Vaccine in Children
Secondary ID [1] 0 0
CSLCT-PAN-05-17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and immunogenicity
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Healthy children aged greater or equal to 6 months to less than 9 years
* Normal gestation period
Minimum age
6 Months
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of clinically significant medical conditions
* History of Guillain Barre syndrome or active neurological disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Murdoch Childrens Research Institute - Melbourne
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terry M Nolan, Prof
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00370864