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Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

NCT ID: NCT01019837

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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:

* Records of adverse event
* Assessment of disease activity : CDAI and MAYO score

Conditions

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Influenza H1N1

Keywords

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Vaccine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Focetria (Monovalent MF59-Adjuvanted vaccine)

Intervention Type BIOLOGICAL

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Interventions

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Focetria (Monovalent MF59-Adjuvanted vaccine)

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Principal Investigators

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Iris Dotan, Dr.

Role: STUDY_DIRECTOR

Tel-Aviv Sourasky Medical Center

Other Identifiers

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TASMC-09-ID-553-CTIL

Identifier Type: -

Identifier Source: org_study_id