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Trial record 1 of 1 for:    NCT00518492
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Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

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.
 
ClinicalTrials.gov Identifier: NCT00518492
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : September 16, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 16, 2007
First Posted Date  ICMJE August 20, 2007
Last Update Posted Date September 16, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Immunogenicity at 6 and 12 months post 6108A1-500 study. [ Time Frame: 6 and 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2007)
Immunogenicity at 6 and 12 months post 6108A1-500 study.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Official Title  ICMJE Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Procedure: Blood Sampling
Blood draws at 6 and 12 months following end of 6108A1-500 trial.
Study Arms  ICMJE 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
Intervention: Procedure: Blood Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2009)
73
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00518492
Other Study ID Numbers  ICMJE 6108A1-1002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia: medinfo@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP