ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids - NCT00546819-Bruxelles - 000 (Clinical Trial 188176)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy188176.aspx
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Bruxelles |
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Country:
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Belgium |
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| Conditions: |
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Herpes Zoster |
| Purpose: |
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The purpose of the study is to determine whether ZOSTAVAX™ is safe, generally well
tolerated, and immunogenic in patients on chronic/maintenance corticosteroids.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Varicella-history positive, herpes zoster (HZ)-history negative patients
- 60 years of age and older receiving chronic/maintenance systemic corticosteroid
therapy at a daily dose of 5 to 20 mg of prednisone or equivalent during the 2 weeks
immediately prior to enrollment and expected to continue to receive a daily dose of 5
to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period
(dose may vary within this range during the 6-week post vaccination period)
Exclusion Criteria:
- Patients with a history of hypersensitivity reaction to gelatin or neomycin
- Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
- Immune globulin and/or blood products given within 5 months prior to or expected
within the 6-week post vaccination period
- Receipt of any live virus vaccinations within 1 month or receipt of any inactivated
vaccinations within 7 days prior to enrollment
- Known immune deficiency that is caused by a medical condition
- Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other
medications which may suppress the immune system including methotrexate,
corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent,
agents used to treat cancer, or medications which alter the level of the immune
response used to treat arthritis or other illnesses
- Concomitant use of antiviral therapy
- All females enrolling must be postmenopausal
- A history of alcohol abuse or recreational drug use |
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| Study is available at: |
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Merck Sharp & Dohme B.V.
Bruxelles
Belgium
Primary Contact:
Nathalie Schrameijer
Phone: 32-2-373-4310
Secondary Contact:
Toll Free Number
Phone: 1-888-577-8839 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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