NCT00518492

Brief Summary

Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2007

Typical duration for phase_1 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

August 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

8 months

First QC Date

August 16, 2007

Last Update Submit

September 15, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity at 6 and 12 months post 6108A1-500 study.

    6 and 12 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Includes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity

Procedure: Blood Sampling

Interventions

Blood SamplingPROCEDURE

Blood draws at 6 and 12 months following end of 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 (three doses administered and visit 9 completed).

You may not qualify if:

  • Bleeding diathesis or condition associated with prolonged bleeding time.
  • Any clinically significant chronic disease that, in the investigators 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
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

AU(3)