Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00500032

Purpose

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.

Condition	Intervention
Healthy	Procedure: blood draw

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500

Further study details as provided by Wyeth:

Primary Outcome Measures:

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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Active Comparator for all subjects enrolled in 6108A1-500	Procedure: blood draw Blood draw from subjects previously vaccinated in 6108A1-500 trial

Detailed Description:

The purpose of this protocol is to analyze the collection of blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As such, the inclusion and exclusion criteria are consistent with the Australian Red Cross guidelines for blood donation.

The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized, placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086 with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon completion of participation in the 6108A1-500 study, subjects will be approached to participate in this blood sampling study. The sites participating in this blood sampling study are the same sites participating in the 6108A1-500 study.

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Main Inclusion Criteria:

Completed study 6108A1-500.
Hemoglobin level ≥12.0 and ≤16.5 g/dL for female subjects and ≥13.0 and ≤18.5 g/dL for male subjects.
Body weight ≥45 and ≤120 kg.
Systolic blood pressure >90 and <180 mm Hg.
Diastolic blood pressure >60 and <100 mm Hg.
Able to be contacted by telephone.
For all female subjects: have a negative urine pregnancy test unless the subject is surgically sterile.

Main Exclusion Criteria:

Bleeding diathesis or condition associated with prolonged bleeding time.
Prior antibiotic use (within 14 days).
Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500032

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Australia, Queensland
	Recruiting
Herson, Queensland, Australia, 4006
Australia, South Australia
	Recruiting
North Adealaide, South Australia, Australia, 5006
Australia, Western Australia
	Recruiting
Perth, Western Australia, Australia, 6840

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Australia: medinfo@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6108A1-1000
Study First Received:	July 11, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00500032
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Wyeth:

Adult

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009