At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 279 enrolled
Drug / intervention
HD-TIV +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?
McGill University Health Centre/Research Institute of the McGill University Health Centre·interventional·Posted Oct 18, 2016·Updated Aug 13, 2024
In Brief
A Phase 4 clinical trial evaluating HD-TIV and SD-QIV for Rheumatoid Arthritis. Completed, enrolled 279 participants across 1 site.
Detailed Summary
Patients with rheumatoid arthritis have increased risk of seasonal influenza and influenza-related complications but have reduced vaccine immunogenicity. It is unknown whether patients with rheumatoid arthritis would benefit from more immunogenic vaccine formulations. This study investigated the immunogenicity and safety of a high-dose trivalent inactivated influenza vaccine (HD-TIV) in patients with rheumatoid arthritis compared to a standard-dose quadrivalent influenza vaccine (SD-QIV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCanada
CollaboratorsThe Arthritis Society, Canada
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionJul 2018
Study CompletionDec 2018
TodayJul 2026
First PostedOct 18, 2016
Enrollment StartOct 1, 2016
Primary CompletionJul 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.7 years ago
Interventions
HD-TIVbiological
SD-QIVbiological