Table 3.
Adverse Events Following Immunization With Either Ad26.RSV.preF or Placebo Intramuscularly (Full Analysis Set)a
| Event or Abnormality | Ad26.RSV.preF (n = 31) | Placebo (n = 32) |
|---|---|---|
| Solicited local AEs | ||
| Any solicited local AE | 31 (100.0) | 6 (18.8) |
| Pain/tenderness | 31 (100.0) | 6 (18.8) |
| Swelling/induration | 9 (29.0) | 1 (3.1) |
| Erythema | 1 (3.2) | 0 (0.0) |
| Any solicited local AE of grade 3/4 | 0 (0.0) | 0 (0.0) |
| Solicited systemic AEs | ||
| Any solicited systemic AE | 31 (100.0) | 16 (50.0) |
| Myalgia | 28 (90.3) | 4 (12.5) |
| Fatigue | 26 (83.9) | 12 (37.5) |
| Headache | 26 (83.9) | 8 (25.0) |
| Chills | 17 (54.8) | 2 (6.3) |
| Arthralgia | 14 (45.2) | 2 (6.3) |
| Nausea | 11 (35.5) | 2 (6.3) |
| Fever | 4 (12.9) | 1 (3.1) |
| Any solicited systemic AE of grade 3 | 3 (9.7) | 1 (3.1) |
| Any solicited systemic AE of grade 4 | 0 (0.0) | 0 (0.0) |
| Unsolicited AEs | ||
| Postimmunization | ||
| Any unsolicited AE | 11 (35.5) | 15 (46.9) |
| Headache | 1 (3.2) | 4 (12.5) |
| Postchallengea | ||
| Any unsolicited AE | 20 (74.1) | 18 (69.2) |
| Increased ALT | 7 (25.9) | 3 (11.5) |
| Dry skin | 3 (11.1) | 2 (7.7) |
| Epistaxis | 0 (0.0) | 3 (11.5) |
| Lymphadenopathy | 6 (22.2) | 1 (3.8) |
| Pharyngitis | 3 (11.1) | 4 (15.4) |
| Rhinorrhea | 1 (3.7) | 4 (15.4) |
Data are presented as No. (%).
Abbreviations: AE, adverse event; ALT, alanine aminotransferase.
aUnsolicited AEs postchallenge were collected from the intent-to-treat challenge population (Ad26.RSV.preF, n = 27; placebo, n = 26). Solicited AEs were defined (local and systemic) events that volunteers were specifically asked about and which were noted by volunteers in a diary in the evening after immunization and then daily for the next 7 days, which was reviewed by the investigator. Solicited AEs are presented in order of decreasing incidence in the Ad26.RSV.preF group and were based on the full analysis set (volunteers who were randomized and received at least 1 dose of the study vaccine). The severity of solicited AEs were graded in the diary by the volunteer based on the severity assessment provided in the diary and then verified by the investigator. For unsolicited AEs, only events occurring in at least 10% of volunteers in 1 arm per period are shown.