Numbers of “Definite,” “Probable,” and “Possible” Cases of Adverse Events of Special Interest Arising During the 6-Month Time Window Following Receipt of ATIV (n = 88,449) and TIV (n = 82,539) Among Vaccinees Aged ≥65 Years (Secondary Analysis), Lombardy, Italy, 2006–2009
| Outcome . | TIV . | ATIV . | Difference . | |||||
|---|---|---|---|---|---|---|---|---|
| No. of Cases . | Riska . | 95% CI . | No. of Cases . | Riska . | 95% CI . | Riska . | 95% CI . | |
| Anaphylaxis | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.00, 6.30 | 1.13 | −1.09, 3.35 |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 1 | 1.21 | 0.03, 6.75 | 2 | 2.26 | 0.27, 8.17 | 1.05 | −2.88, 4.98 |
| Convulsions | 41 | 49.67 | 35.65, 67.39 | 39 | 44.09 | 31.36, 60.27 | −5.58 | −26.12, 14.97 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 1 | 1.21 | 0.03, 6.75 | 0 | 0.00 | 0.00, 4.17 | −1.21 | −3.59, 1.16 |
| Guillain-Barré syndrome | 4 | 4.85 | 1.32, 12.41 | 1 | 1.13 | 0.03, 6.30 | −3.72 | −8.96, 1.53 |
| Immune thrombocytopenic purpura | 1 | 1.21 | 0.03, 6.75 | 3 | 3.39 | 0.70, 9.91 | 2.18 | −2.33, 6.69 |
| Vasculitis | 1 | 1.21 | 0.03, 6.75 | 5 | 5.65 | 1.84, 13.19 | 4.44 | −1.05, 9.94 |
| Outcome . | TIV . | ATIV . | Difference . | |||||
|---|---|---|---|---|---|---|---|---|
| No. of Cases . | Riska . | 95% CI . | No. of Cases . | Riska . | 95% CI . | Riska . | 95% CI . | |
| Anaphylaxis | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.00, 6.30 | 1.13 | −1.09, 3.35 |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 1 | 1.21 | 0.03, 6.75 | 2 | 2.26 | 0.27, 8.17 | 1.05 | −2.88, 4.98 |
| Convulsions | 41 | 49.67 | 35.65, 67.39 | 39 | 44.09 | 31.36, 60.27 | −5.58 | −26.12, 14.97 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 1 | 1.21 | 0.03, 6.75 | 0 | 0.00 | 0.00, 4.17 | −1.21 | −3.59, 1.16 |
| Guillain-Barré syndrome | 4 | 4.85 | 1.32, 12.41 | 1 | 1.13 | 0.03, 6.30 | −3.72 | −8.96, 1.53 |
| Immune thrombocytopenic purpura | 1 | 1.21 | 0.03, 6.75 | 3 | 3.39 | 0.70, 9.91 | 2.18 | −2.33, 6.69 |
| Vasculitis | 1 | 1.21 | 0.03, 6.75 | 5 | 5.65 | 1.84, 13.19 | 4.44 | −1.05, 9.94 |
Abbreviations: ATIV, adjuvanted trivalent inactivated vaccine; CI, confidence interval; N/A, not available; TIV, trivalent inactivated vaccine.
a Cumulative incidence (number of cases per 100,000 persons).
Numbers of “Definite,” “Probable,” and “Possible” Cases of Adverse Events of Special Interest Arising During the 6-Month Time Window Following Receipt of ATIV (n = 88,449) and TIV (n = 82,539) Among Vaccinees Aged ≥65 Years (Secondary Analysis), Lombardy, Italy, 2006–2009
| Outcome . | TIV . | ATIV . | Difference . | |||||
|---|---|---|---|---|---|---|---|---|
| No. of Cases . | Riska . | 95% CI . | No. of Cases . | Riska . | 95% CI . | Riska . | 95% CI . | |
| Anaphylaxis | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.00, 6.30 | 1.13 | −1.09, 3.35 |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 1 | 1.21 | 0.03, 6.75 | 2 | 2.26 | 0.27, 8.17 | 1.05 | −2.88, 4.98 |
| Convulsions | 41 | 49.67 | 35.65, 67.39 | 39 | 44.09 | 31.36, 60.27 | −5.58 | −26.12, 14.97 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 1 | 1.21 | 0.03, 6.75 | 0 | 0.00 | 0.00, 4.17 | −1.21 | −3.59, 1.16 |
| Guillain-Barré syndrome | 4 | 4.85 | 1.32, 12.41 | 1 | 1.13 | 0.03, 6.30 | −3.72 | −8.96, 1.53 |
| Immune thrombocytopenic purpura | 1 | 1.21 | 0.03, 6.75 | 3 | 3.39 | 0.70, 9.91 | 2.18 | −2.33, 6.69 |
| Vasculitis | 1 | 1.21 | 0.03, 6.75 | 5 | 5.65 | 1.84, 13.19 | 4.44 | −1.05, 9.94 |
| Outcome . | TIV . | ATIV . | Difference . | |||||
|---|---|---|---|---|---|---|---|---|
| No. of Cases . | Riska . | 95% CI . | No. of Cases . | Riska . | 95% CI . | Riska . | 95% CI . | |
| Anaphylaxis | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.00, 6.30 | 1.13 | −1.09, 3.35 |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 1 | 1.21 | 0.03, 6.75 | 2 | 2.26 | 0.27, 8.17 | 1.05 | −2.88, 4.98 |
| Convulsions | 41 | 49.67 | 35.65, 67.39 | 39 | 44.09 | 31.36, 60.27 | −5.58 | −26.12, 14.97 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 1 | 1.21 | 0.03, 6.75 | 0 | 0.00 | 0.00, 4.17 | −1.21 | −3.59, 1.16 |
| Guillain-Barré syndrome | 4 | 4.85 | 1.32, 12.41 | 1 | 1.13 | 0.03, 6.30 | −3.72 | −8.96, 1.53 |
| Immune thrombocytopenic purpura | 1 | 1.21 | 0.03, 6.75 | 3 | 3.39 | 0.70, 9.91 | 2.18 | −2.33, 6.69 |
| Vasculitis | 1 | 1.21 | 0.03, 6.75 | 5 | 5.65 | 1.84, 13.19 | 4.44 | −1.05, 9.94 |
Abbreviations: ATIV, adjuvanted trivalent inactivated vaccine; CI, confidence interval; N/A, not available; TIV, trivalent inactivated vaccine.
a Cumulative incidence (number of cases per 100,000 persons).
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