Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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
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 May 22, 2013