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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01713855 |
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Date of registration:
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18/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
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Scientific title:
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Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP) |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01713855 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Ellis J Neufeld, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previously or currently enrolled in parent study, see CHB 02-12-160
Exclusion Criteria:
- Baseline immunodeficiency (i.e. DiGeorge syndrome, Common Variable Immunodeficiency)
- Contraindications for influenza vaccine, including: hypersensitivity to egg products;
history of Guillain-Barre syndrome; history of adverse reaction to flu vaccine
- Contraindications for tetanus toxoid, including: hypersensitivity to prior tetanus
vaccination; concurrent moderate to severe illness
- Subjects meeting any of the following criteria will be temporarily excluded from the
study: high-dose corticosteroid therapy (5-30 mg/kg/day) during the 24 hours
immediately prior to the vaccine; IVIG (intravenous immunoglobulin) within 4 months
prior to vaccine; platelet count of less than 20,000/ml within one month of
vaccination with evidence of grade II or higher skin bleeding, assessed at vaccine
administration
Age minimum:
18 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Thrombocytopenic Purpura
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Immune Thrombocytopenic Purpura
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Intervention(s)
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Biological: Inactivated Trivalent Influenza vaccine
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Primary Outcome(s)
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The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination
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Secondary Outcome(s)
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The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination
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The number of patients with any increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination.
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The number of patients with any increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination
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Secondary ID(s)
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CHB 04-10-143
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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