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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019837

Enrollment

200

Registered

2009-11-25

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza H1N1

Keywords

Vaccine

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

Interventions

BIOLOGICALFocetria (Monovalent MF59-Adjuvanted vaccine)

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects	4 weeks

Secondary

Measure	Time frame
Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score	4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026