|
Main
|
|
Note: This record shows only the 20 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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01019837 |
|
Date of registration:
|
22/11/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics
|
|
Scientific title:
|
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics |
|
Date of first enrolment:
|
November 2009 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01019837 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
|
Contacts
|
|
Name:
|
Iris Dotan, Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tel-Aviv Sourasky Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patients suffering from IBD (inflammatory bowel disease): UC/ CD
2. Able to firm an informed consent
3. Aged - 18-65
4. Candidates to receive vaccination against H1N1, according to the recommendation of
the Ministry of Health
5. patients who treated with immunomodulators and biologics
Exclusion Criteria:
1. Allergy to eggs
2. Known allergy to seasonal influenza vaccine
3. Pregnant women
4. Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot
seasonal influenza
5. Patients without worsening in their disease condition (stable condition)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Influenza H1N1
|
|
Intervention(s)
|
|
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
|
|
Primary Outcome(s)
|
|
Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
[Time Frame: 4 weeks]
|
|
Secondary Outcome(s)
|
|
Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
TASMC-09-ID-553-CTIL
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|