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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518492
First Posted: August 20, 2007
Last Update Posted: September 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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
Healthy Procedure: Blood Sampling Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518492


Locations
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia: medinfo@wyeth.com
  More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00518492     History of Changes
Other Study ID Numbers: 6108A1-1002
First Submitted: August 16, 2007
First Posted: August 20, 2007
Last Update Posted: September 16, 2009
Last Verified: September 2009