Table 4.
Any and Grade 3 solicited local and systemic adverse events (AE) within 6 days after administration of study vaccine
| AE | Cohort A % (n) | Cohort B % (n) | Cohort C % (n) | ||
|---|---|---|---|---|---|
| Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | |
| Any local solicited AE | 36·1 (254) | 27·2 (167) | 58·5 (512) | 49·2 (312) | 70·6 (281) |
| Any Grade 3 event | 0·6 (4) | 0·5 (3) | 3·5 (31) | 2·1 (13) | 3·8 (15) |
| Pain | 22·8 (160) | 18·0 (111) | 52·9 (463) | 44·5 (282) | 68·1 (271) |
| Grade 3 | 0·1 (1) | 0·3 (2) | 0·2 (2) | 0·3 (2) | 0·3 (1) |
| Redness (erythema) | 22·1 (148) | 17·7 (109) | 21·6 (189) | 17·2 (109) | 16·6 (66) |
| Grade 3 | 0·3 (2) | 0·2 (1) | 2·1 (18) | 1·1 (7) | 2·0 (8) |
| Injection site swelling (induration) or lump | 9·4 (66) | 10·4 (64) | 15·7 (137) | 12·1 (77) | 13·1 (52) |
| Grade 3 | 0·3 (2) | 0 | 2·2 (19) | 1·3 (8) | 3·0 (12) |
| Any systemic solicited AE | 60·3 (424) | 42·4 (261) | 39·5 (346) | 24·8 (157) | 42·7 (170) |
| Any Grade 3 event | 5·7 (40) | 2·3 (14) | 2·7 (24) | 2·1 (13) | 1·0 (4) |
| Fever | 28·6 (201) | 17·9 (110) | 19·5 (171) | 9·9 (63) | 5·0 (20) |
| Grade 3 | 1·8 (13) | 1·0 (6) | 0·8 (7) | 0·3 (2) | 0 |
| Headache | 3·6 (25) | 2·0 (12) | 15·5 (136) | 6·0 (38) | 26·9 (107) |
| Grade 3 | 0·1 (1) | 0 | 0·5 (4) | 0·6 (4) | 0·5 (2) |
| Myalgia | 3·7 (26) | 2·6 (16) | 9·9 (87) | 5·4 (34) | 20·1 (80) |
| Grade 3 | 3 (0·4) | 0·2 (1) | 3 (0·3) | 0·5 (3) | 0 |
| Nausea/vomiting | 11·2 (79) | 5·0 (31) | 8·6 (75) | 3·9 (25) | 5·3 (21) |
| Grade 3 | 1·7 (12) | 0·7 (4) | 0·7 (6) | 0·8 (5) | 0·3 (1) |
| Diarrhoea | 14·2 (100) | 8·5 (52) | 4·6 (40) | 3·2 (20) | 5·3 (21) |
| Grade 3 | 0·6 (4) | 0·5 (3) | 0·2 (2) | 0 | 0·3 (1) |
| Loss of appetite (Cohort A only) | 20·1 (141) | 13·3 (8·2) | – | – | – |
| Grade 3 | 1·1 (8) | 0·7 (4) | – | – | – |
| Irritability (Cohort A only) | 42·0 (295) | 28·5 (175) | – | – | – |
| Grade 3 | 3·4 (24) | 1·1 (7) | – | – | – |
| Malaise (Cohorts B and C only) | – | – | 20·5 (179) | 11·4 (72) | 16·6 (66) |
| Grade 3 | – | – | 1·6 (14) | 1·6 (10) | 0·3 (1) |