NCT00500032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

1.4 years

First QC Date

July 11, 2007

Last Update Submit

September 15, 2009

Conditions

Healthy

Keywords

Adult

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL

Active Comparator for all subjects enrolled in 6108A1-500

Procedure: blood draw

Interventions

blood drawPROCEDURE

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

Arm 1

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Herson, Queensland, 4006, Australia

Location

Unknown Facility

North Adealaide, South Australia, 5006, Australia

Location

Unknown Facility

Perth, Western Australia, 6840, Australia

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Australia: medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

AU(3)