Number (%) of Subjects With Reactogenicity Events, Adverse Events, or Other Safety Events
| . | . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| Event, n (%)a . | Placebo N = 45 . | 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . |
| Reactogenicityb | |||||||
| Any | 28 (62.2) | 44 (100.0) | 44 (97.8) | 44 (100.0) | 44 (100.0) | 43 (97.7) | 43 (97.7) |
| Grade 1 (Mild) | 10 (22.2) | 7 (15.9) | 7 (15.6) | 4 (9.1) | 3 (6.8) | 6 (13.6) | 4 (9.1) |
| Grade 2 (Moderate) | 16 (35.6) | 26 (59.1) | 28 (62.2) | 27 (61.4) | 31 (70.5) | 19 (43.2) | 20 (45.5) |
| Grade 3 (Severe) | 2 (4.4) | 11 (25.0) | 9 (20.0) | 13 (29.5) | 10 (22.7) | 18 (40.9) | 19 (43.2) |
| Grade 4 (Life-threatening) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any local reaction | 14 (31.1) | 43 (97.7) | 44 (97.8) | 43 (97.7) | 42 (95.5) | 43 (97.7) | 42 (95.5) |
| Any systemic event | 26 (57.8) | 41 (93.2) | 42 (93.3) | 41 (93.2) | 40 (90.9) | 42 (95.5) | 41 (93.2) |
| AEs | |||||||
| Any | 24 (53.3) | 22 (50.0) | 22 (48.9) | 28 (63.6) | 26 (59.1) | 23 (52.3) | 18 (40.9) |
| Grade 1 (Mild) | 18 (40.0) | 16 (36.4) | 13 (28.9) | 18 (40.9) | 17 (38.6) | 20 (45.5) | 13 (29.5) |
| Grade 2 (Moderate) | 7 (15.6) | 9 (20.5) | 12 (26.7) | 12 (27.3) | 12 (27.3) | 12 (27.3) | 10 (22.7) |
| Grade 3 (Severe) | 3 (6.7) | 0 | 6 (13.3) | 4 (9.1) | 1 (2.3) | 4 (9.1) | 2 (4.5) |
| Grade 4 (Life-threatening) | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 0 | 1 (2.3) | 1 (2.3) |
| SAEs | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| Treatment-related AEsc | 5 (11.1) | 8 (18.2) | 10 (22.2) | 13 (29.5) | 9 (20.5) | 13 (29.5) | 11 (25.0) |
| Treatment-related SAEsc | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to reactogenicity | 0 | 0 | 1 (2.2) | 1 (2.3) | 0 | 0 | 1 (2.3) |
| Discontinuation due to AEs | 0 | 0 | 1 (2.2) | 0 | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| . | . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| Event, n (%)a . | Placebo N = 45 . | 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . |
| Reactogenicityb | |||||||
| Any | 28 (62.2) | 44 (100.0) | 44 (97.8) | 44 (100.0) | 44 (100.0) | 43 (97.7) | 43 (97.7) |
| Grade 1 (Mild) | 10 (22.2) | 7 (15.9) | 7 (15.6) | 4 (9.1) | 3 (6.8) | 6 (13.6) | 4 (9.1) |
| Grade 2 (Moderate) | 16 (35.6) | 26 (59.1) | 28 (62.2) | 27 (61.4) | 31 (70.5) | 19 (43.2) | 20 (45.5) |
| Grade 3 (Severe) | 2 (4.4) | 11 (25.0) | 9 (20.0) | 13 (29.5) | 10 (22.7) | 18 (40.9) | 19 (43.2) |
| Grade 4 (Life-threatening) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any local reaction | 14 (31.1) | 43 (97.7) | 44 (97.8) | 43 (97.7) | 42 (95.5) | 43 (97.7) | 42 (95.5) |
| Any systemic event | 26 (57.8) | 41 (93.2) | 42 (93.3) | 41 (93.2) | 40 (90.9) | 42 (95.5) | 41 (93.2) |
| AEs | |||||||
| Any | 24 (53.3) | 22 (50.0) | 22 (48.9) | 28 (63.6) | 26 (59.1) | 23 (52.3) | 18 (40.9) |
| Grade 1 (Mild) | 18 (40.0) | 16 (36.4) | 13 (28.9) | 18 (40.9) | 17 (38.6) | 20 (45.5) | 13 (29.5) |
| Grade 2 (Moderate) | 7 (15.6) | 9 (20.5) | 12 (26.7) | 12 (27.3) | 12 (27.3) | 12 (27.3) | 10 (22.7) |
| Grade 3 (Severe) | 3 (6.7) | 0 | 6 (13.3) | 4 (9.1) | 1 (2.3) | 4 (9.1) | 2 (4.5) |
| Grade 4 (Life-threatening) | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 0 | 1 (2.3) | 1 (2.3) |
| SAEs | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| Treatment-related AEsc | 5 (11.1) | 8 (18.2) | 10 (22.2) | 13 (29.5) | 9 (20.5) | 13 (29.5) | 11 (25.0) |
| Treatment-related SAEsc | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to reactogenicity | 0 | 0 | 1 (2.2) | 1 (2.3) | 0 | 0 | 1 (2.3) |
| Discontinuation due to AEs | 0 | 0 | 1 (2.2) | 0 | 2 (4.5) | 1 (2.3) | 1 (2.3) |
Abbreviations: AE, adverse event; SAE, serious adverse event.
aSubjects are counted once in each category in which they have data.
bReactogenicity events occurring within 7 days after any dose of GEN-003 or placebo.
cTreatment-related AEs/SAEs are AEs/SAEs with relationship to investigational product assessed by the investigator as likely.
Number (%) of Subjects With Reactogenicity Events, Adverse Events, or Other Safety Events
| . | . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| Event, n (%)a . | Placebo N = 45 . | 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . |
| Reactogenicityb | |||||||
| Any | 28 (62.2) | 44 (100.0) | 44 (97.8) | 44 (100.0) | 44 (100.0) | 43 (97.7) | 43 (97.7) |
| Grade 1 (Mild) | 10 (22.2) | 7 (15.9) | 7 (15.6) | 4 (9.1) | 3 (6.8) | 6 (13.6) | 4 (9.1) |
| Grade 2 (Moderate) | 16 (35.6) | 26 (59.1) | 28 (62.2) | 27 (61.4) | 31 (70.5) | 19 (43.2) | 20 (45.5) |
| Grade 3 (Severe) | 2 (4.4) | 11 (25.0) | 9 (20.0) | 13 (29.5) | 10 (22.7) | 18 (40.9) | 19 (43.2) |
| Grade 4 (Life-threatening) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any local reaction | 14 (31.1) | 43 (97.7) | 44 (97.8) | 43 (97.7) | 42 (95.5) | 43 (97.7) | 42 (95.5) |
| Any systemic event | 26 (57.8) | 41 (93.2) | 42 (93.3) | 41 (93.2) | 40 (90.9) | 42 (95.5) | 41 (93.2) |
| AEs | |||||||
| Any | 24 (53.3) | 22 (50.0) | 22 (48.9) | 28 (63.6) | 26 (59.1) | 23 (52.3) | 18 (40.9) |
| Grade 1 (Mild) | 18 (40.0) | 16 (36.4) | 13 (28.9) | 18 (40.9) | 17 (38.6) | 20 (45.5) | 13 (29.5) |
| Grade 2 (Moderate) | 7 (15.6) | 9 (20.5) | 12 (26.7) | 12 (27.3) | 12 (27.3) | 12 (27.3) | 10 (22.7) |
| Grade 3 (Severe) | 3 (6.7) | 0 | 6 (13.3) | 4 (9.1) | 1 (2.3) | 4 (9.1) | 2 (4.5) |
| Grade 4 (Life-threatening) | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 0 | 1 (2.3) | 1 (2.3) |
| SAEs | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| Treatment-related AEsc | 5 (11.1) | 8 (18.2) | 10 (22.2) | 13 (29.5) | 9 (20.5) | 13 (29.5) | 11 (25.0) |
| Treatment-related SAEsc | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to reactogenicity | 0 | 0 | 1 (2.2) | 1 (2.3) | 0 | 0 | 1 (2.3) |
| Discontinuation due to AEs | 0 | 0 | 1 (2.2) | 0 | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| . | . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| Event, n (%)a . | Placebo N = 45 . | 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . |
| Reactogenicityb | |||||||
| Any | 28 (62.2) | 44 (100.0) | 44 (97.8) | 44 (100.0) | 44 (100.0) | 43 (97.7) | 43 (97.7) |
| Grade 1 (Mild) | 10 (22.2) | 7 (15.9) | 7 (15.6) | 4 (9.1) | 3 (6.8) | 6 (13.6) | 4 (9.1) |
| Grade 2 (Moderate) | 16 (35.6) | 26 (59.1) | 28 (62.2) | 27 (61.4) | 31 (70.5) | 19 (43.2) | 20 (45.5) |
| Grade 3 (Severe) | 2 (4.4) | 11 (25.0) | 9 (20.0) | 13 (29.5) | 10 (22.7) | 18 (40.9) | 19 (43.2) |
| Grade 4 (Life-threatening) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any local reaction | 14 (31.1) | 43 (97.7) | 44 (97.8) | 43 (97.7) | 42 (95.5) | 43 (97.7) | 42 (95.5) |
| Any systemic event | 26 (57.8) | 41 (93.2) | 42 (93.3) | 41 (93.2) | 40 (90.9) | 42 (95.5) | 41 (93.2) |
| AEs | |||||||
| Any | 24 (53.3) | 22 (50.0) | 22 (48.9) | 28 (63.6) | 26 (59.1) | 23 (52.3) | 18 (40.9) |
| Grade 1 (Mild) | 18 (40.0) | 16 (36.4) | 13 (28.9) | 18 (40.9) | 17 (38.6) | 20 (45.5) | 13 (29.5) |
| Grade 2 (Moderate) | 7 (15.6) | 9 (20.5) | 12 (26.7) | 12 (27.3) | 12 (27.3) | 12 (27.3) | 10 (22.7) |
| Grade 3 (Severe) | 3 (6.7) | 0 | 6 (13.3) | 4 (9.1) | 1 (2.3) | 4 (9.1) | 2 (4.5) |
| Grade 4 (Life-threatening) | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 0 | 1 (2.3) | 1 (2.3) |
| SAEs | 0 | 1 (2.3) | 2 (4.4) | 1 (2.3) | 2 (4.5) | 1 (2.3) | 1 (2.3) |
| Treatment-related AEsc | 5 (11.1) | 8 (18.2) | 10 (22.2) | 13 (29.5) | 9 (20.5) | 13 (29.5) | 11 (25.0) |
| Treatment-related SAEsc | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to reactogenicity | 0 | 0 | 1 (2.2) | 1 (2.3) | 0 | 0 | 1 (2.3) |
| Discontinuation due to AEs | 0 | 0 | 1 (2.2) | 0 | 2 (4.5) | 1 (2.3) | 1 (2.3) |
Abbreviations: AE, adverse event; SAE, serious adverse event.
aSubjects are counted once in each category in which they have data.
bReactogenicity events occurring within 7 days after any dose of GEN-003 or placebo.
cTreatment-related AEs/SAEs are AEs/SAEs with relationship to investigational product assessed by the investigator as likely.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
