Trial Review

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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00370864
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00370864