Table 4.
Incidence rate (per 100,000 person-years) and estimated relative risk in controlled trials for medically-attended events by preferred terms with the 95% CI of the relative risk excluding 1.0 (total vaccinated cohorts)
| H5N1/ A(H1N1)pdm09 AS03 N = 13,325 T = 7448.8 |
Control N = 6,361 T = 4,389 |
RR (AS03 over Control) |
||||
|---|---|---|---|---|---|---|
| MedDRA Preferred Term | n | IR (95% CI) | n | IR (95% CI) | RR (95% CI) | p-value interact |
| At least one MAE | 3208 | 43067.1 (41586.4; 44580.6) | 1931 | 43995.9 (42049.9; 45997.5) | 0.99 (0.93; 1.05) | 0.259 |
| Diarrhea | 38 | 510.1 (361.0; 700.2) | 10 | 227.8 (109.3; 419.0) | 2.91 (1.40; 6.63) | 0.399 |
| Gastroesophageal reflux disease | 36 | 483.3 (338.5; 669.1) | 38 | 865.8 (612.7; 1188.4) | 0.51 (0.31; 0.86) | 0.463 |
| Injection site swelling* | 0 | 0 (0; 49.5) | 4 | 91.1 (24.8; 233.3) | 0 (0; 0.63) | 1.000 |
| Seasonal allergy | 14 | 187.9 (102.8; 315.3) | 2 | 45.6 (5.5; 164.6) | 4.94 (1.09; 45.80) | 0.761 |
| Vulvovaginal candidiasis | 10 | 134.2 (64.4; 246.9) | 1 | 22.8 (0.6; 126.9) | 7.96 (1.09; 350.95) | 0.543 |
| Musculoskeletal chest pain | 9 | 120.8 (55.2; 229.4) | 18 | 410.1 (243.1; 648.2) | 0.34 (0.13; 0.83) | 0.639 |
| Allergic rhinitis | 4 | 53.7 (14.6; 137.5) | 9 | 205.1 (93.8; 389.3) | 0.22 (0.05; 0.85) | 0.855 |
| Cystitis** | 42 | 615.8 (443.8; 832.3) | 15 | 341.8 (191.3; 563.7) | 1.93 (1.03; 3.83) | 0.185 |
| Carpal tunel syndrome*** | 0 | 0 (0; 83.5) | 3 | 222.5 (45.9; 650.2) | 0 (0; 0.74) | 1.000 |
| Fall*** | 0 | 0 (0; 83.5) | 3 | 222.5 (45.9; 650.2) | 0 (0; 0.81) | not calculated |
N, total number of participants; T, total follow-up time in year calculated as sum of (Ns*Ts); n, number of participants reporting at least one event; 95% CI, exact 95% Confidence Interval; IR, incidence rate (per 100,000 person-years) of participants reporting at least one event; RR, Relative Risk (AS03-adjuvanted vaccine over Control group) adjusted by study effect; p-value interact, 2-sided Exact Breslow and Day Test for heterogeneity
*Solicited AE with a duration >4 days.
** For cystitis the incidence rate (per 100,000 person-years) and estimated RR was calculated in AS03A-adjuvanted vaccines and control groups based on controlled trials only.
*** For carpal tunel syndrome and fall the incidence rates (per 100,000 person-years) and estimated RRs were calculated in AS03-adjuvanted H5N1 vaccines and control groups based on controlled trials only. For ‘fall’, the three events were reported in the same trial while for ‘carpal tunnel syndrome’, the events were reported in two different trials. Therefore, the p-values could be calculated for ‘carpal tunnel syndrome’ but not for ‘fall’.