Table 1. Summary safety data–adverse events during main trial¶.
| IM 20 μg(n = 11) | IM 100 μg (n = 9) | Intranasal (n = 5) | IM + IVAG (n = 11) | |
|---|---|---|---|---|
| Primary Safety outcome: | 0 | 0 | 0 | 0 |
| SAEs: | 2* | 0 | 0 | 0 |
| Total Solicited adverse events: | 69 | 39 | 24 | 62 |
| No. of events; Grade 1 | 63 | 37 | 24 | 60 |
| No. of events: Grade 2 | 6 | 2 | 0 | 2 |
| No. of subjects with any event | 11 | 9 | 5 | 11 |
| Median no. of events per subject | 6 | 4 | 2 | 5 |
| Max grade per subject: Grade 1 | 8 | 8 | 5 | 10 |
| Max grade per subject: Grade 2 | 3 | 1 | 0 | 1 |
| Total No. of subjects with local events | 11 | 7 | 5 | 9 |
| Injection-site | 10 | 7 | 0 | 9 |
| Nasal | 1 | 0 | 5 | 1 |
| Intravaginal | 4 | 0 | 0 | 4 |
| No. of subjects with systemic event | 8 | 4 | 1 | 8 |
| No. of subjects with lab event | 2 | 5 | 3 | 6 |
| Unsolicited adverse events | ||||
| No. of events: | 36 | 33 | 27 | 34 |
| No. of subjects with any event | 8 | 8 | 5 | 10 |
| Median no. of events per subject | 2 | 2 | 5 | 2 |
Table 1 footnotes:
¶ before boosting phase; there were no grade 3 or 4 solicited adverse events.
* Two serious adverse events were reported, the first was a suspected (accidental) paracetamol overdose, the second, a Bartholin abscess. Since this individual was not in the IVAG group the cyst was considered unlikely vaccine related.