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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Completed study 6108A1-500 (three doses administered and visit 9 completed).
Minimum age
18 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
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
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Wyeth is now a wholly owned subsidiary of Pfizer

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Other publications