This trial is active, not recruiting.

Condition influenza h1n1
Treatment focetria (monovalent mf59-adjuvanted vaccine)
Sponsor Tel-Aviv Sourasky Medical Center
Start date November 2009
End date November 2009
Trial size 200 participants
Trial identifier NCT01019837, TASMC-09-ID-553-CTIL


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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
focetria (monovalent mf59-adjuvanted vaccine) Focetria (Monovalent MF59-Adjuvanted vaccine)
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center.