Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01019837
First received: November 22, 2009
Last updated: November 23, 2009
Last verified: November 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 22, 2009 | ||||
| Last Updated Date | November 23, 2009 | ||||
| Start Date ICMJE | November 2009 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01019837 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics | ||||
| Official Title ICMJE | Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics | ||||
| Brief Summary | The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs. |
||||
| Detailed Description | 200 patients with IBD and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later. The evaluation will include: Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test. Safety of the vaccine:
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Influenza H1N1 | ||||
| Intervention ICMJE | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Other Name: Focetria (Monovalent MF59-Adjuvanted vaccine) |
||||
| Study Arm (s) | Experimental: Monovalent MF59- Adjuvanted vaccine
Focetria (Monovalent MF59-Adjuvanted vaccine) 7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate Intra muscular
Intervention: Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) |
||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | April 2010 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01019837 | ||||
| Other Study ID Numbers ICMJE | TASMC-09-ID-553-CTIL | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Tel-Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | November 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||