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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00500032

Enrollment

Registered

2007-07-12

Start date

2007-03-31

Completion date

2008-08-31

Last updated

2009-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Adult

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.

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.

Interventions

PROCEDUREblood draw

Blood draw from subjects previously vaccinated in 6108A1-500 trial

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026