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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 August 2024 |
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Main ID: |
NCT02936180 |
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Date of registration:
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07/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Standard Versus High Dose Inactivated Influenza Vaccine in RA
IV-RA |
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Scientific title:
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Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population? |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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279 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02936180 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Ines Colmegna, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Centre/Research Institute of the McGill University Health Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of seropositive RA (rheumatoid factor (RF) and/or anti-CCP antibody
positive) based on the 2010 ACR-EULAR criteria.
2. At least 6 months of treatment including anti-TNF agents, abatacept, rituximab (dose
received within the previous 6 months) and/or methotrexate.
3. Informed consent form signed and dated.
4. Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
1. Vaccination against influenza in the 6 months preceding the trial vaccination.
2. Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
components, or a history of a life-threatening reaction to TIV or to a vaccine
containing any of the same substances.
3. History of Guillain-Barré syndrome within six weeks of a previous influenza
vaccination.
4. Dementia or any other cognitive condition that could interfere with the trial
procedures.
5. Thrombocytopenia or bleeding disorder contraindicating IM vaccination (according to
treating rheumatologist).
6. Current alcohol abuse or drug addiction.
7. Moderate or severe acute illness with or without fever. If this exists, vaccination
will be deferred until the individual has been medically stable and/or afebrile for
at least 24 hours.
8. Signs and symptoms of an acute infectious respiratory illness. If this exists,
vaccination will be deferred until the symptoms resolve.
9. Pregnant women (the rationale for excluding this group is not their lack of
indication for vaccination but the changes of maternal immune responses during
pregnancy)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Biological: HD-TIV
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Biological: SD-QIV
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Primary Outcome(s)
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Seroprotection Rate to HD- Versus SD-IV in People With RA
[Time Frame: Day 28]
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Seroconversion Rate to HD- Versus SD-IV in People With RA
[Time Frame: Day 28]
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Geometric Mean Titres (GMTs) of HI in People With RA Who Received HD- Versus SD-IV
[Time Frame: Day 28]
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Secondary Outcome(s)
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Durability of Detectable Levels of HI Antibody for SD- and HD- IV.
[Time Frame: Day 186]
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Rates of Side Effects During the Surveillance Period in SD- and HD-IV.
[Time Frame: Day 28]
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Secondary ID(s)
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MP-37-2017-2773
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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