Overview of solicited and unsolicited adverse events
| Group 1: 140 µg F-protein-FP/2 mg BLP | Group 2: 350 µg F-protein-FP/5 mg BLP | Placebo | ||||||
|---|---|---|---|---|---|---|---|---|
| Post prime (n=18) | Post boost (n=17) | Post prime (n=18) | Post boost (n=18) | Post prime (n=12) | Post boost (n=12) | |||
| n (% of subjects with events) | ||||||||
| Local solicited AEs | ||||||||
| Loss of smell | 3 (16.7) | 4 (23.5) | 1 (5.6) | 0 | 2 (16.7) | 0 | ||
| Nasal discomfort | 2 (11.1) | 3 (17.6) | 3 (16.7) | 4 (22.2) | 3 (25.0) | 1 (8.3) | ||
| Nasal pain | 1 (5.6) | 0 | 1 (5.6) | 2 (11.1) | 1 (8.3) | 0 | ||
| Rhinorrhea | 8 (44.4) | 4 (23.5) | 6 (33.3) | 4 (22.2) | 3 (25.0) | 2 (16.7) | ||
| stuffy nose | 8 (44.4) | 5 (29.4) | 6 (33.3) | 4 (22.2) | 4 (33.3) | 6 (50.0) | ||
| Sneezing | 6 (33.3) | 2 (11.8) | 1 (5.6) | 3 (16.7) | 2 (16.7) | 2 (16.7) | ||
| Sore throat | 2 (11.1) | 1 (5.9) | 5 (27.8) | 3 (16.7) | 3 (25.0) | 5 (41.7) | ||
| Solicited systemic AEs | ||||||||
| Arthralgia | 1 (5.6) | 2 (11.8) | 1 (5.6) | 1 (5.6) | 0 | 0 | ||
| Fatigue | 9 (50.0) | 7 (41.2) | 6 (33.3) | 6 (33.3) | 7 (58.3) | 5 (41.7) | ||
| Feeling feverish | 2 (11.1) | 1 (5.6) | 1 (5.6) | 1 (5.6) | 1 (8.3) | 1 (8.3) | ||
| Headache | 8 (44.4) | 4 (23.5) | 8 (44.4) | 8 (44.4) | 4 (33.3) | 2 (16.7) | ||
| Malaise | 2 (11.8) | 2 (11.8) | 2 (11.1) | 0 | 1 (8.3) | 1 (8.3) | ||
| Myalgia | 5 (27.8) | 3 (17.6) | 0 | 2 (11.1) | 2 (16.7) | 1 (8.3) | ||
| All unsolicited AEs | ||||||||
| Oro-pharyngeal pain | 0 | 0 | 1 (5.6) | 5 (27.8) | 1 (8.3) | 1 (8.3) | ||
| Cough | 0 | 1 (5.6) | 3 (16.7) | 1 (5.6) | 0 | 1 (8.3) | ||