Table 2. Risk of narcolepsy ± narcolepsy associated with A/H1N1 (2009) vaccination using the cohort method according to observation period and post-vaccination risk period, in Quebec, 2009–2010.
Observation period | Risk period from dateof vaccination to: | No cases | Incidence rate | Age- and gender-adjusted risk ratio | Attributable cases/million doses(95% confidence intervals) | |||||||
E+ | E− | Total | E+ | E− | Total | RR | ICinf | ICsup | P-value | |||
January 1st 2009, toDecember 31, 2010 | End study periodDecember 31st, 2010 | 8 | 15 | 23 | 0.164 | 0.253 | 0.148 | 1.06 | 39.00 | 2.68 | 1.000 | 0.25 [−2.83 to 1.13] |
One year (365 days)post-vaccination | 8 | 15 | 23 | 0.181 | 0.464 | 0.148 | 1.24 | 0.45 | 3.13 | 0.650 | 0.46 [−2.21 to 1.23] | |
24 weeks (168 days)post-vaccination | 7 | 16 | 23 | 0.344 | 1.039 | 0.148 | 2.73 | 0.95 | 7.04 | 0.063 | 1.04 [−0.08 to 1.36] | |
16 weeks (112 days)post-vaccination* | 7 | 16 | 23 | 0.516 | 1.237 | 0.148 | 4.32 | 1.50 | 11.12 | 0.007 | 1.24 [0.53 to 1.44] | |
8 weeks (56 days)post-vaccination | 4 | 19 | 23 | 0.590 | 0.709 | 0.148 | 4.36 | 1.08 | 13.15 | 0.039 | 0.71 [0.07 to 0.84] | |
May 1st 2009, toMarch 31 2010 | End study periodDecember 31st, 2010 | 7 | 12 | 19 | 0.448 | 0.822 | 0.266 | 1.91 | 0.63 | 5.28 | 0.272 | 0.82 [−0.93 to 1.28] |
One year (365 days)post-vaccination | 7 | 12 | 19 | 0.448 | 0.822 | 0.266 | 1.91 | 0.63 | 5.28 | 0.272 | 0.82 [−0.93 to 1.28] | |
24 weeks (168 days)post-vaccination | 7 | 12 | 19 | 0.448 | 0.822 | 0.266 | 1.91 | 0.63 | 5.28 | 0.272 | 0.82 [−0.93 to 1.28] | |
16 weeks (112 days)post-vaccination | 7 | 12 | 19 | 0.516 | 0.947 | 0.266 | 2.33 | 0.77 | 6.43 | 0.138 | 0.95 [−0.47 to 1.34] | |
8 weeks (56 days)post-vaccination | 4 | 15 | 19 | 0.590 | 0.549 | 0.266 | 2.39 | 0.58 | 7.52 | 0.233 | 0.55 [−0.66 to 0.78] | |
October 4 2009, toMarch 31 2010 | End study periodDecember 31st, 2010 | 7 | 3 | 10 | 0.448 | 0.133 | 0.262 | 2.73 | 0.62 | 16.45 | 0.234 | 1.11 [−0.97 to 1.49] |
One year (365 days)post-vaccination | 7 | 3 | 10 | 0.448 | 0.133 | 0.262 | 2.73 | 0.62 | 16.45 | 0.234 | 1.11 [−0.97 to 1.49] | |
24 weeks (168 days)post-vaccination | 7 | 3 | 10 | 0.448 | 0.133 | 0.262 | 2.73 | 0.62 | 16.45 | 0.234 | 1.11 [−0.97 to 1.49] | |
16 weeks (112 days)post-vaccination | 7 | 3 | 10 | 0.516 | 0.122 | 0.262 | 3.63 | 0.82 | 21.82 | 0.098 | 1.21 [−0.35 to 1.51] | |
8 weeks (56 days)post-vaccination | 4 | 6 | 10 | 0.590 | 0.191 | 0.262 | 2.73 | 0.57 | 11.55 | 0.229 | 0.61 [−0.68 to 0.83] |
+: Cases with onset after vaccination during risk period; E−: Cases not vaccinated or with onset before vaccination or after end of risk period.
*Primary analysis defined a priori.