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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00518492
First received: August 16, 2007
Last updated: September 15, 2009
Last verified: September 2009
  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: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on August 18, 2014