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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500032
• Other study ID #: 6108A1-1000
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: September 15, 2009
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• blood draw
Blood draw from subjects previously vaccinated in 6108A1-500 trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No