Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Blood Sampling

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herson, Queensland, Australia, 4006
  • South Australia
    • North Adealaide, South Australia, Australia, 5006
  • Western Australia
    • Perth, Western Australia, Australia, 6840

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Completed study 6108A1-500 (three doses administered and visit 9 completed).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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; Blood draws at 6 and 12 months following end of 6108A1-500 trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity at 6 and 12 months post 6108A1-500 study.	6 and 12 months

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Australia: medinfo@wyeth.com

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 17, 2007
• First Posted (Estimate): August 20, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2009
• Last Update Submitted That Met QC Criteria: September 15, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 6108A1-1002