Table 2.
Overview of solicited and unsolicited adverse events
| Group: | E | A | B | C | D |
|---|---|---|---|---|---|
| AE Category Severity/Relationship | Placebo N = 60 | 60 μg + Al N = 40 | 60 μg N = 40 | 90 μg + Al N = 40 | 90 μg N = 40 |
| Verbatim Term | n (% of Subjects with Events) | ||||
| Local Solicited AEsa | 14 (23) | 17 (43) | 9 (23) | 17 (43) | 15 (38) |
| Severe | 0 | 0 | 0 | 0 | 0 |
| Pain | 14 (23) | 17 (43) | 8 (20) | 17 (43) | 10 (25) |
| Swelling | 2 (3) | 4 (10) | 1 (3) | 3 (8) | 6 (15) |
| Bruising | 1 (2) | 2 (5) | 1 (3) | 1 (3) | 4 (10) |
| Redness | 0 | 0 | 1 (3) | 2 (5) | 3 (8) |
| Solicited Systemic AEsa | 22 (37) | 12 (30) | 6 (15) | 16 (40) | 10 (25) |
| Severe | 1 (2) | 1 (3) | 0 | 0 | 1 (3) |
| Muscle Pain | 6 (10) | 6 (15) | 4 (10) | 7 (18) | 5 (13) |
| Joint Pain | 4 (7) | 4 (10) | 2 (5) | 1 (3) | 4 (10) |
| Headache | 10 (17) | 2 (5) | 5 (13) | 9 (23) | 3 (8) |
| Fatigue | 12 (20) | 4 (10) | 2 (5) | 6 (15) | 8 (20) |
| All Unsolicited AEsb | 36 (60) | 19 (48) | 23 (58) | 19 (48) | 22 (55) |
| Related | 6 (10) | 1 (3) | 0 | 1 (3) | 4 (10) |
| Severe | 4 (7) | 2 (5) | 3 (8) | 2 (5) | 0 |
| Severe/Related | 0 | 0 | 0 | 0 | 0 |
| Severe or Related | 10 (17) | 3 (8) | 3 (8) | 3 (8) | 4 (10) |
| Upper Respiratory Tract Infection | 6 (10) | 2 (5) | 3 (8) | 1 (3) | 2 (5) |
| Back Pain | 1 (2) | 1 (3) | 1 (3) | 4 (10) | 2 (5) |
| Myalgia | 0 | 0 | 1 (3) | 2 (5) | 3 (8) |
| Oropharyngeal Pain | 1 (2) | 3 (8) | 1 (3) | 1 (3) | 0 |
| Hypertension | 1 (2) | 2 (5) | 0 | 2 (5) | 1 (3) |
| Systolic Hypertension | 1 (2) | 1 (3) | 2 (5) | 0 | 2 (5) |
| SAEsb | 3 (5) | 2 (5) | 3 (8) | 3 (8) | 1 (3) |
| MAEsb | 21 (35) | 11 (28) | 14 (35) | 8 (20) | 14 (35) |
| SNMCsb | 4 (7) | 2 (5) | 5 (13) | 2 (5) | 4 (10) |
- Percentages are based on the number of subjects in the Safety Population with the event shown. Subjects with multiple events within a category were counted only once, using the event with the greatest severity (mild, moderate, severe) and/or relationship (possible, probable, definite). An AE was considered treatment-emergent if it began on or after the day 0 vaccination
aOnly includes solicited AEs with an onset within 7 days of the day 0 vaccination. All solicited events were deemed to be related to the test article administered
bIncludes unsolicited AEs with an onset from days 0 to 56; and significant new medical conditions (SNMCs), medically-attended adverse events (MAEs), and serious adverse events (SAEs) with an onset from days 0 to 364. The unsolicited AEs shown are those that occurred in > 2% of subjects (i.e., 4 or more) in an RSV F vaccine group