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/NCT00320346




Registration number
NCT00320346
Ethics application status
Date submitted
1/05/2006
Date registered
3/05/2006
Date last updated
19/07/2016

Titles & IDs
Public title
Phase II Study of Pandemic Influenza Vaccine
Scientific title
A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (=18 Years to =64 Years of Age).
Secondary ID [1] 0 0
CSLCT-PAN-05-18
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
Secondary outcome [1] 0 0
Lot to Lot Consistency
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Healthy Adults
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Previous vaccination with an influenza Vaccine containing the H5N1 strain
* History of clinically significant medical conditions
* History of Guillian-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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
CMAX, a division of IDT Australia - Adelaide
Recruitment hospital [2] 0 0
Murdoch Childrens Research Institute - Melbourne
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment postcode(s) [3] 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
Peter Richmond, Dr
Address 0 0
Princess Margaret Hospital for Children
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/NCT00320346