Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00376402




Registration number
NCT00376402
Ethics application status
Date submitted
11/09/2006
Date registered
14/09/2006
Date last updated
19/07/2016

Titles & IDs
Public title
Study of a Pandemic Influenza Vaccine in Elderly Participants
Scientific title
Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants
Secondary ID [1] 0 0
CSLCT-PAN-05-24
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
Other interventions - H5N1 Pandemic Influenza Vaccine

Other interventions: H5N1 Pandemic Influenza Vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
- Healthy male and female participants
Minimum age
65 Years
Maximum age
No limit
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

- Resident of nursing home or long-term care facility

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
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
CMAX, a division of IDT Australia - Adelaide
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6840 - 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 H5N1 virus strain is one of the leading candidates to cause the next influenza
pandemic. The elderly are likely to be a special target group for vaccination; therefore,
this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a
healthy elderly population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00376402
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00376402