Table 3.
Ratios1, [percentages], and (95% confidence intervals) of local or systemic elicited adverse events {AE} of any severity (grades 1 to 3) or of maximum grade 3 severity after each of the three anthrax vaccine adsorbed dose.
| Diary collected after dose given at week: ages group | Week Zero: Dose 1 | Week Two: Dose 2 | Week Four: Dose 3 | P-value2 for trend testing |
|---|---|---|---|---|
| Anygrade 1–3 local AE | ||||
| 18 to 20 years | 60/74 [81.1%] (70.3, 89.3) | 59/71 [83.1] (72.3, 90.9) | 52/71 [73.2%] (61.4, 83.1) | 0.263 |
| 21 to 29 years | 207/242 [85.5%] (80.5, 89.7) | 200/236 [84.7%] (79.5, 89.1) | 186/230 [80.9%] (75.2, 85.7) | 0.190 |
| Any maximum grade 3 local AE | ||||
| 18 to 20 years | 5/74 [6.8%] (2.2,15.1) | 3/71 [4.2%] (0.9,11.9) | 0/71 [0%] (0, 5.1) | 0.045 |
| 21 to 29 years | 13/242 [5.4%] (2.9, 9.0) | 7/236 [3.0%] (1.2, 6.0) | 4/230 [1.7%] (0.5, 4.4) | 0.030 |
| Anygrade 1–3 systemic AE | ||||
| 18 to 20 years | 42/74 [56.8%] (44.7, 68.2) | 34/71 [47.9%] (35.9, 60.1) | 22/71 [31.0%] (20.5, 43.1) | 0.002 |
| 21 to 29 years | 136/242 [56.2%] (49.7, 62.5) | 121/235 [51.5%] (44.9, 58.0) | 100/230 [43.5%] (37.0, 50.2) | 0.007 |
| Any maximum grade 3 systemic AE | ||||
| 18 to 20 years | 2/74 [2.7%] (0.3, 9.4) | 5/71 [7.0%] (2.3,15.7) | 0/71 [0%] (0, 5.1) | 0.489 |
| 21 to 29 years | 9/242 [3.7%] (1.7, 6.9) | 7/235 [3.0%] (1.2, 6.0) | 3/230 [1.3%] (0.2,3.8) | 0.119 |
1
Ratios represent numbers of diaries collected with at least one grade 1 to 3 elicited AE within 7 days of vaccination (numerator) and total number of diaries collected at dose 1, 2 or 3 (denominator).
2
Note: significant P values (<0.05) are shown in bold text. Cochran–Armitage test was used to test the trend over the three consecutive AVA doses.