Table 4.
Group III | Group VI | Group VII | |||
---|---|---|---|---|---|
Booster dose | 1st dose | 2nd dose | 1st dose | 2nd dose | |
N=33 | N=46 | N=46 | N=50 | N=50 | |
Local symptoms | |||||
Any | 31 (94%) | 41 (89%) | 35 (78%) | 47 (94%) | 41 (82%) |
Pain | |||||
Any | 31 (94%) | 41 (89%) | 34 (76%) | 47 (94%) | 41 (82%) |
Severe | 6 (18%) | 8 (17%) | 2 (4%) | 6 (12%) | 3 (6%) |
Erythema | |||||
Any | 8 (24%) | 7 (16%) | 6 (13%) | 8 (16%) | 7 (14%) |
Severe | 1 (3%) | 1 (2%) | 0 | 0 | 0 |
Induration | |||||
Any | 12 (36%) | 7 (15%) | 9 (20%) | 13 (26%) | 8(16%) |
Severe | 0 | 0 | 0 | 1 (2%) | 0 |
General symptoms | |||||
Any | 24 (73%) | 35 (76%) | 22 (49%) | 37 (74%) | 28 (56%) |
Chills | |||||
Any | 5 (15%) | 11 (24%) | 5 (11%) | 11 (22%) | 9 (18%) |
Severe | 1 (3%) | 0 | 1 (2%) | 0 | 1 (2%) |
Loss of appetite | |||||
Any | 5 (15%) | 9 (20%) | 3 (7%) | 9 (18%) | 5 (10%) |
Severe | 0 | 0 | 0 | 1 (2%) | 2 (4%) |
Headache | |||||
Any | 19 (58%) | 20 (43%) | 11 (25%) | 23 (46%) | 18 (36%) |
Severe | 0 | 1 (2%) | 2 (5%) | 3 (6%) | 4 (8%) |
Fatigue | |||||
Any | 14 (42%) | 19 (42%) | 10 (23%) | 24 (48%) | 12 (24%) |
Severe | 0 | 1 (2%) | 1 (2%) | 0 | 1 (2%) |
Myalgia | |||||
Any | 18 (55%) | 22 (48%) | 12 (27%) | 23 (46%) | 14 (28%) |
Severe | 0 | 0 | 1 (2%) | 1 (2%) | 2 (4%) |
Arthralgia | |||||
Any | 8 (24%) | 8 (17%) | 4 (9%) | 15 (30%) | 7 (14%) |
Severe | 0 | 0 | 1 (2%) | 0 | 1 (2%) |
Nausea | |||||
Any | 4 (12%) | 10 (22%) | 4 (9%) | 13 (26%) | 4 (8%) |
Severe | 0 | 1 (2%) | 0 | 0 | 0 |
Fever | |||||
Any(≥38°C) | 0 | 4 (9%) | 4 (9%) | 8 (16%) | 2 (4%) |
Severe(≥40°C) | 0 | 0 | 0 | 0 | 0 |
Unsolicited symptoms | 11 (33%) | 21 (46%) | 20 (40%) | ||
Possibly related unsolicited AEs | 3 (9%) | 11 (24%) | 8 (16%) | ||
Medically-attended AEs | 2 (6%) | 6 (13%) | 5 (10%) | ||
SAEs | 0 | 0 | 0 |
Footnote: N, maximum number of participants with available results; AE, adverse event; SAE, serious adverse event.