Numbers of “Definite,” “Probable,” “Possible,” and “Cannot Be Ruled Out” Cases of Adverse Events of Special Interest Arising During the Biologically Plausible Time Windows Following Receipt of ATIV (n = 88,449) and TIV (n = 82,539) Among Vaccinees Aged ≥65 Years (Secondary Sensitivity 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 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.03, 6.30 | 1.13 | −1.09, 3.35 |
| Convulsions | 7 | 8.48 | 3.41, 17.47 | 4 | 4.52 | 1.23, 11.58 | −3.96 | −11.65, 3.73 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Guillain-Barré syndrome | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Immune thrombocytopenic purpura | 3 | 3.63 | 0.75, 10.62 | 4 | 4.52 | 1.23, 11.58 | 0.89 | −5.16, 6.93 |
| Vasculitis | 0 | 0.00 | 0.00, 4.47 | 3 | 3.39 | 0.70, 9.91 | 3.39 | −0.45, 7.23 |
| 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 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.03, 6.30 | 1.13 | −1.09, 3.35 |
| Convulsions | 7 | 8.48 | 3.41, 17.47 | 4 | 4.52 | 1.23, 11.58 | −3.96 | −11.65, 3.73 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Guillain-Barré syndrome | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Immune thrombocytopenic purpura | 3 | 3.63 | 0.75, 10.62 | 4 | 4.52 | 1.23, 11.58 | 0.89 | −5.16, 6.93 |
| Vasculitis | 0 | 0.00 | 0.00, 4.47 | 3 | 3.39 | 0.70, 9.91 | 3.39 | −0.45, 7.23 |
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,” “Possible,” and “Cannot Be Ruled Out” Cases of Adverse Events of Special Interest Arising During the Biologically Plausible Time Windows Following Receipt of ATIV (n = 88,449) and TIV (n = 82,539) Among Vaccinees Aged ≥65 Years (Secondary Sensitivity 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 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.03, 6.30 | 1.13 | −1.09, 3.35 |
| Convulsions | 7 | 8.48 | 3.41, 17.47 | 4 | 4.52 | 1.23, 11.58 | −3.96 | −11.65, 3.73 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Guillain-Barré syndrome | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Immune thrombocytopenic purpura | 3 | 3.63 | 0.75, 10.62 | 4 | 4.52 | 1.23, 11.58 | 0.89 | −5.16, 6.93 |
| Vasculitis | 0 | 0.00 | 0.00, 4.47 | 3 | 3.39 | 0.70, 9.91 | 3.39 | −0.45, 7.23 |
| 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 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Autoimmune hepatitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Bell's palsy | 0 | 0.00 | 0.00, 4.47 | 1 | 1.13 | 0.03, 6.30 | 1.13 | −1.09, 3.35 |
| Convulsions | 7 | 8.48 | 3.41, 17.47 | 4 | 4.52 | 1.23, 11.58 | −3.96 | −11.65, 3.73 |
| Demyelinating disorders | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Encephalitis | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Guillain-Barré syndrome | 0 | 0.00 | 0.00, 4.47 | 0 | 0.00 | 0.00, 4.17 | 0.00 | N/A |
| Immune thrombocytopenic purpura | 3 | 3.63 | 0.75, 10.62 | 4 | 4.52 | 1.23, 11.58 | 0.89 | −5.16, 6.93 |
| Vasculitis | 0 | 0.00 | 0.00, 4.47 | 3 | 3.39 | 0.70, 9.91 | 3.39 | −0.45, 7.23 |
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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