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Trial details imported from

For full trial details, please see the original record at

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

Titles & IDs
Public title
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Scientific title
Blood Collection for Use in Serological Assay Development From 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 draw

Experimental: Arm 1 - Active Comparator for all subjects enrolled in 6108A1-500

Treatment: Surgery: blood draw
Blood draw from subjects previously vaccinated in 6108A1-500 trial

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Primary objective is to obtain blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500, for use in serological assay development.
Timepoint [1] 0 0
1 Year

Key inclusion criteria

1. Completed study 6108A1-500.

2. Hemoglobin level =12.0 and =16.5 g/dL for female subjects and =13.0 and =18.5 g/dL for
male subjects.

3. Body weight =45 and =120 kg.

4. Systolic blood pressure >90 and <180 mm Hg.

5. Diastolic blood pressure >60 and <100 mm Hg.

6. Able to be contacted by telephone.

7. For all female subjects: have a negative urine pregnancy test unless the subject is
surgically sterile.

Minimum age
18 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Bleeding diathesis or condition associated with prolonged bleeding time.

2. Prior antibiotic use (within 14 days).

3. Any clinically significant chronic disease that, in the investigator's judgment may be
worsened by blood draw.

Study design
Purpose of the study
Allocation to intervention
Non-randomised 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?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
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
Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine
or placebo was administered, will be approached for inclusion into this study which is purely
for blood draw. The sera will be used for assay development.
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