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/ct2/show/NCT00500032




Registration number
NCT00500032
Ethics application status
Date submitted
11/07/2007
Date registered
12/07/2007
Date last updated
16/09/2009

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
6108A1-1000
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 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

Outcomes
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

Eligibility
Key inclusion criteria
Main

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.

Main
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Diagnosis
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
Parallel
Other design features
Phase
Not Applicable
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
87
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
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
https://clinicaltrials.gov/ct2/show/NCT00500032
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/NCT00500032