NCT01019837

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

November 22, 2009

Last Update Submit

November 23, 2009

Conditions

Influenza H1N1

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    4 weeks

Study Arms (1)

Monovalent MF59- Adjuvanted vaccine

EXPERIMENTAL

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

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Interventions

Focetria (Monovalent MF59-Adjuvanted vaccine)BIOLOGICAL

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Monovalent MF59- Adjuvanted vaccine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from IBD (inflammatory bowel disease): UC/ CD
  • Able to firm an informed consent
  • Aged - 18-65
  • Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
  • patients who treated with immunomodulators and biologics

You may not qualify if:

  • Allergy to eggs
  • Known allergy to seasonal influenza vaccine
  • Pregnant women
  • Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza
  • Patients without worsening in their disease condition (stable condition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

focetria

Study Officials

  • Iris Dotan, Dr.

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 22, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

April 1, 2010

Last Updated

November 25, 2009

Record last verified: 2009-11