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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: August 16, 2007
Last updated: September 15, 2009
Last verified: September 2009

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.

Condition Intervention Phase
Procedure: Blood Sampling
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Immunogenicity at 6 and 12 months post 6108A1-500 study. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00518492

Australia, Queensland
Herson, Queensland, Australia, 4006
Australia, South Australia
North Adealaide, South Australia, Australia, 5006
Australia, Western Australia
Perth, Western Australia, Australia, 6840
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia:
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00518492     History of Changes
Other Study ID Numbers: 6108A1-1002
Study First Received: August 16, 2007
Last Updated: September 15, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration processed this record on April 15, 2014