Last reviewed · How we verify
Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population? (IV-RA)
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).
Details
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 279 |
| Start date | 2016-10 |
| Completion | 2018-12 |
Conditions
- Rheumatoid Arthritis
Interventions
- HD-TIV
- SD-QIV
Primary outcomes
- Seroconversion Rate to HD- Versus SD-IV in People With RA — Day 28
Seroconversion rate (SCR): proportion of subjects in a given treatment group (SD- or HD) with either a ≥4-fold increase in reciprocal HI titres between D0 and D28 or a rise of undetectable HI titre (i.e. \<1:10) pre-vaccination (D0) to an HI titre of ≥1:40 at D28 post vaccination. - Seroprotection Rate to HD- Versus SD-IV in People With RA — Day 28
Seroprotection rate (SPR): the proportion of subjects in a given treatment group attaining a reciprocal HI titre of ≥1:40 at D28 post-vaccination. - Geometric Mean Titres (GMTs) of HI in People With RA Who Received HD- Versus SD-IV — Day 28
Geometric mean titres (GMTs) of HI at D28.
Countries
Canada