Table 3.
Adverse Events in the Intention-to-Treat Safety Cohort.*
| Event | HSV-Vaccine Group (N = 4488) | Control Group (N = 3662) | Odds Ratio (95% CI) |
|---|---|---|---|
| no. (%) | |||
| Throughout the study | |||
| Death† | 1 (<1) | 0 (0) | NC |
| Any serious adverse event, new-onset chronic disease, or medically significant condition‡ | 208 (5) | 182 (5) | 0.9 (0.8–1.1) |
| Vaccine-related serious adverse event, new-onset chronic disease, or medically significant condition§ | 10 (<1) | 8 (<1) | NC |
| Within 31 days after administration of any dose¶ | |||
| Vaccine-related serious adverse event | 3 (<1) | 3 (<1) | NC |
| Any unsolicited adverse event | 2154 (48) | 1677 (46) | 1.1 (1.0–1.2) |
| Grade 3 or higher unsolicited adverse event | 305 (7) | 250 (7) | 1.0 (0.8–1.2) |
| Within 7 days after administration of any dose | |||
| Any solicited injection-site event | 3937 (88) | 2641 (72) | 2.8 (2.5–3.1) |
| Redness | 1621 (36) | 702 (19) | 2.4 (2.1–2.6) |
| Swelling | 1371 (31) | 438 (12) | 3.2 (2.9–3.6) |
| Pain | 3902 (87) | 2559 (70) | 2.9 (2.6–3.2) |
| Any solicited systemic event | 2731 (61) | 2071 (57) | 1.2 (1.1–1.3) |
| Fatigue | 2031 (45) | 1503 (41) | 1.2 (1.1–1.3) |
| Fever | 400 (9) | 260 (7) | 1.3 (1.1–1.5) |
| Headache | 1885 (42) | 1456 (40) | 1.1 (1.0–1.2) |
| Malaise | 1459 (33) | 1003 (27) | 1.3 (1.2–1.4) |
The intention-to-treat safety cohort excludes 171 subjects at a single site (which was unable to complete study monitoring as planned owing to a natural disaster) and 2 subjects without any follow-up data after vaccination. NC denotes not calculated.
The only death that occurred (in the HSV-vaccine group) was unrelated to vaccination.
New-onset chronic diseases and medically significant conditions were assessed by medical monitors at GlaxoSmithKline and the National Institutes of Health who were unaware of study assignments.
Events classified as possibly related to vaccination were assessed by an investigator at each site who was unaware of study assignments.
Because of a programming error, 148 subjects received the incorrect product and were offered a fourth dose to complete their assigned vaccination sequence. A total of 112 subjects in the intention-to-treat safety cohort received a fourth dose, and safety data related to dose 4 are included in this analysis.