Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
NCT00518492
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- Completed study 6108A1-500 (three doses administered and visit 9 completed).
- 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.
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Descriptive Information | |||||||
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |