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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00500032
First received: July 11, 2007
Last updated: September 15, 2009
Last verified: September 2009
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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 is now a wholly owned subsidiary of Pfizer:

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 ]

Enrollment: 87
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, Queensland
Herson, Queensland, Australia, 4006
Australia, South Australia
North Adealaide, South Australia, Australia, 5006
Australia, Western Australia
Perth, Western Australia, Australia, 6840
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia: medinfo@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00500032     History of Changes
Other Study ID Numbers: 6108A1-1000
Study First Received: July 11, 2007
Last Updated: September 15, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Adult

ClinicalTrials.gov processed this record on September 29, 2014