Vaccination Against Influenza H1N1 in Rheumatic Diseases
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedNovember 3, 2009
November 1, 2009
5 months
October 31, 2009
November 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint : 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)
Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI
4 weeks
Study Arms (1)
Monovalent MF59-Adjuvanted vaccine
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Patients suffering from: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Psoriatic Arthritis
- Able to firm an informed consent
- Aged - 18-65
- Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
You may not qualify if:
- Allergy to eggs
- Known allergy to seasonal influenza vaccine
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Elkayam O, Amir S, Mendelson E, Schwaber M, Grotto I, Wollman J, Arad U, Brill A, Paran D, Levartovsky D, Wigler I, Caspi D, Mandelboim M. Efficacy and safety of vaccination against pandemic 2009 influenza A (H1N1) virus among patients with rheumatic diseases. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1062-7. doi: 10.1002/acr.20465.
PMID: 21425247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
October 31, 2009
First Posted
November 3, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 3, 2009
Record last verified: 2009-11