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/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
Other
Allocation to intervention
Not applicable
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/study/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/study/NCT00518492