Safety results
pyrexia, influenza-like illness, nasopharyngitis, pain
ADVERSE EVENTS, EVENT, INFLUENZA-LIKE ILLNESS, NASOPHARYNGITIS
Overall, 619 adverse events (AE) occurred within the treatment period, 426 AEs in the StroVac group in 115 patients (62.2%), and 193 AEs in 83 patients in the placebo group (44.1%). By the end of the study, most AEs had resolved (98.7%). Most AEs were mild (54.9%) and moderate (33.4%) in intensity, and 11.6% were classified as severe. Most severe AEs occurred in the StroVac group (55 vs 17 AEs). Most common AEs were vaccination site pain (37.2% in the StroVac group and 5.3% in the placebo group) and influenza-like illness (11.7 and 4.8%, respectively). Most common severe AEs were vaccination site pain, pyrexia and influenza-like illness as well. 63.3% of patients with AEs reported in the StroVac group, and 17% of patients in the placebo group were classified as having drug-related AEs. 88.6% of the patients assessed the tolerability of StroVac as “very good” and “good”.In the observation period after drug administration, 471 AEs occurred, equally in both groups showing 227 AEs in 81 patients in the StroVac group, and 244 AEs in 84 placebo patients. Again, most AEs were mild or moderate, severe AEs were more common in the placebo group. The most commonly reported event was nasopharyngitis (4.8 and 4.3% of all AEs in the StroVac and placebo group, respectively) followed by influenza-like illness (5.3 and 3.7%, respectively). Of all AEs, 2.7% were classified as drug-related in the StroVac group and 1.1% in the placebo group. Again, the majority of AEs had resolved by the end of the study.