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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/NCT00518492




Registration number
NCT00518492
Ethics application status
Date submitted
16/08/2007
Date registered
20/08/2007
Date last updated
16/09/2009

Titles & IDs
Public title
Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Scientific title
Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Secondary ID [1] 0 0
6108A1-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Blood Sampling

Experimental: Arm 1 - Includes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity


Treatment: Surgery: Blood Sampling
Blood draws at 6 and 12 months following end of 6108A1-500 trial.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immunogenicity at 6 and 12 months post 6108A1-500 study.
Timepoint [1] 0 0
6 and 12 months

Eligibility
Key inclusion criteria
- Completed study 6108A1-500 (three doses administered and visit 9 completed).
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Bleeding diathesis or condition associated with prolonged bleeding time.

- Any clinically significant chronic disease that, in the investigators judgment may be
worsened by blood draw.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
- Herson
Recruitment hospital [2] 0 0
- North Adealaide
Recruitment hospital [3] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
4006 - Herson
Recruitment postcode(s) [2] 0 0
5006 - North Adealaide
Recruitment postcode(s) [3] 0 0
6840 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent
for this duration of immunity study to provide up to two additional blood samples. SBA & IgG
testing will be done on these samples taken at 6 & 12 months. The sites participating in this
duration of immunity study are the same sites participating in the 6108A1-500 study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00518492
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
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/NCT00518492