Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers

Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: blood draw

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Main 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.

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Active Comparator for all subjects enrolled in 6108A1-500	Procedure: blood draw; Blood draw from subjects previously vaccinated in 6108A1-500 trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 Year

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Australia: medinfo@wyeth.com

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 11, 2007
• First Submitted That Met QC Criteria: July 11, 2007
• First Posted (Estimate): July 12, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2009
• Last Update Submitted That Met QC Criteria: September 15, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Adult
• Other Study ID Numbers: 6108A1-1000