Trial procedures
rheumatoid
ADVERSE EVENTS, ADVERSE EVENT
Once informed consent was provided, an eligibility assessment was performed for all study participants during a 14-day screening period. Screening assessments included the collection of significant medical history data, baseline safety laboratory assessments (blood and urine) and physical examination. Baseline and follow-up safety bloods included rheumatoid factor by standard commercial assay, and a positive result on this was an exclusion criterion at entry screening. Study vaccines were administered as a 0.5 mL intramuscular deltoid injection on day 1. Post-vaccination follow-up visits were planned for days 8, 29, 91 and 181. Participants recorded the frequency and severity of any solicited local and systemic adverse events in an electronic diary for 7 days after vaccination. Adverse events were graded according to the scale provided in 