Vaccines, Blood & Biologics
List of Tables E.9-hr_12M_PE and Table E.9-hr_6M_PE - Cervarix, August 11, 2009
LIST OF TABLES
Table E.9-hr_12M_PE_irres Incidence rates and vaccine efficacy against persistent infection (12-month definition) with oncogenic HPV types (by PCR) in all subjects, irrespective of their baseline HPV DNA status, using conditional exact method (Total vaccinated cohort) 2
Table E.9-hr_6M_PE_irres Incidence rates and vaccine efficacy against persistent infection (6-month definition) with oncogenic HPV types (by PCR) in all subjects, irrespective of their baseline HPV DNA status, using conditional exact method (Total vaccinated cohort) 4
Table E.9-hr_12M_PE_ irres Incidence rates and vaccine efficacy against persistent infection (12-month definition) with oncogenic HPV types (by PCR) in all subjects, irrespective of their baseline HPV DNA status, using conditional exact method (Total vaccinated cohort)
|
| Person-year rate | VE |
| |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Event Type | Group | N | n | T(year) | n/T (Per 100) | LL | UL | % | LL | UL | P-value |
| HPV-16 | HPV | 8625 | 261 | 24477.95 | 1.07 | 0.93 | 1.21 | 47.4 | 38.2 | 55.2 | <0.0001 |
| HAV | 8648 | 489 | 24147.92 | 2.03 | 1.84 | 2.22 | - | - | - | - | |
| HPV-18 | HPV | 8625 | 83 | 24953.40 | 0.33 | 0.26 | 0.42 | 51.6 | 35.9 | 63.7 | <0.0001 |
| HAV | 8648 | 171 | 24890.15 | 0.69 | 0.58 | 0.80 | - | - | - | - | |
| HPV-31 | HPV | 8625 | 135 | 24839.36 | 0.54 | 0.45 | 0.65 | 38.5 | 22.5 | 51.3 | <0.0001 |
| HAV | 8648 | 219 | 24799.65 | 0.88 | 0.76 | 1.01 | - | - | - | - | |
| HPV-33 | HPV | 8625 | 80 | 25000.95 | 0.32 | 0.25 | 0.40 | 25.8 | -1.5 | 46.0 | 0.0475 |
| HAV | 8648 | 108 | 25030.93 | 0.43 | 0.35 | 0.53 | - | - | - | - | |
| HPV-35 | HPV | 8625 | 58 | 25056.51 | 0.23 | 0.17 | 0.30 | -35.4 | -110.3 | 12.1 | 0.1355 |
| HAV | 8648 | 43 | 25154.58 | 0.17 | 0.12 | 0.23 | - | - | - | - | |
| HPV-39 | HPV | 8625 | 140 | 24868.76 | 0.56 | 0.47 | 0.67 | 0.4 | -28.4 | 22.7 | 1.0000 |
| HAV | 8648 | 141 | 24949.24 | 0.57 | 0.47 | 0.67 | - | - | - | - | |
| HPV-45 | HPV | 8625 | 40 | 25082.43 | 0.16 | 0.11 | 0.22 | 36.4 | 1.9 | 59.2 | 0.0292 |
| HAV | 8648 | 63 | 25136.75 | 0.25 | 0.19 | 0.32 | - | - | - | - | |
| HPV-51 | HPV | 8625 | 245 | 24635.27 | 0.99 | 0.87 | 1.13 | 19.0 | 2.9 | 32.4 | 0.0149 |
| HAV | 8648 | 302 | 24609.96 | 1.23 | 1.09 | 1.38 | - | - | - | - | |
| HPV-52 | HPV | 8625 | 325 | 24475.01 | 1.33 | 1.18 | 1.49 | 1.8 | -15.7 | 16.7 | 0.8115 |
| HAV | 8648 | 332 | 24549.27 | 1.35 | 1.20 | 1.51 | - | - | - | - | |
| HPV-56 | HPV | 8625 | 113 | 24941.49 | 0.45 | 0.37 | 0.55 | 9.4 | -19.4 | 31.3 | 0.4729 |
| HAV | 8648 | 125 | 24989.60 | 0.50 | 0.41 | 0.60 | - | - | - | - | |
| HPV-58 | HPV | 8625 | 127 | 24924.85 | 0.51 | 0.42 | 0.61 | -20.4 | -59.6 | 8.9 | 0.1663 |
| HAV | 8648 | 106 | 25054.36 | 0.42 | 0.34 | 0.52 | - | - | - | - | |
| HPV-59 | HPV | 8625 | 55 | 25075.02 | 0.22 | 0.16 | 0.29 | -25.5 | -95.1 | 18.8 | 0.2693 |
| HAV | 8648 | 44 | 25170.71 | 0.17 | 0.12 | 0.24 | - | - | - | - | |
| HPV-66 | HPV | 8625 | 117 | 24935.45 | 0.47 | 0.38 | 0.57 | -3.0 | -36.3 | 22.2 | 0.8427 |
| HAV | 8648 | 114 | 25019.09 | 0.46 | 0.37 | 0.55 | - | - | - | - | |
| HPV-68 | HPV | 8625 | 104 | 24951.42 | 0.42 | 0.34 | 0.51 | 2.5 | -30.8 | 27.3 | 0.8899 |
| HAV | 8648 | 107 | 25035.65 | 0.43 | 0.35 | 0.52 | - | - | - | - | |
| HPV-HRW | HPV | 8625 | 1211 | 22457.92 | 5.39 | 5.08 | 5.72 | 9.6 | 1.8 | 16.8 | 0.0113 |
| HAV | 8648 | 1333 | 22341.33 | 5.97 | 5.63 | 6.31 | - | - | - | - | |
| HPV-HR | HPV | 8625 | 1414 | 21883.10 | 6.46 | 6.11 | 6.83 | 17.5 | 11.1 | 23.5 | <0.0001 |
| HAV | 8648 | 1683 | 21481.16 | 7.83 | 7.45 | 8.24 | - | - | - | - | |
HPV = HPV-16/18 L1 VLP AS04 vaccine (three lots) = Vaccine group
HAV = Hepatitis A vaccine (three lots) = Control group
N=number of subjects included in each group
Follow-up period starts at first visit
Subjects have at least 10 months of follow-up after first visit
n=number of subjects reporting at least one event in each group
HPV-HRW = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18
HPV-HR = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
T(years)=sum of follow-up period (censored at the first occurrence of an event) expressed in years in each group
n/T=Incidence rate of subjects reporting at least one event
VE(%)=Vaccine Efficacy (conditional exact method)
LL,UL=96.1% Lower and Upper confidence limits
P-value=Two-sided Fisher Exact test
Table E.9-hr_6M_PE_ irres Incidence rates and vaccine efficacy against persistent infection (6-month definition) with oncogenic HPV types (by PCR) in all subjects, irrespective of their baseline HPV DNA status, using conditional exact method (Total vaccinated cohort)
|
| Person-year rate | VE |
| |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Event Type | Group | N | n | T(year) | n/T (Per 100) | LL | UL | % | LL | UL | P-value |
| HPV-16 | HPV | 8856 | 390 | 24273.94 | 1.61 | 1.44 | 1.78 | 55.2 | 49.1 | 60.6 | <0.0001 |
| HAV | 8859 | 848 | 23631.27 | 3.59 | 3.34 | 3.85 | - | - | - | - | |
| HPV-18 | HPV | 8856 | 141 | 24932.96 | 0.57 | 0.47 | 0.67 | 63.0 | 54.5 | 70.1 | <0.0001 |
| HAV | 8859 | 377 | 24659.97 | 1.53 | 1.37 | 1.70 | - | - | - | - | |
| HPV-31 | HPV | 8856 | 223 | 24764.90 | 0.90 | 0.78 | 1.03 | 44.3 | 33.6 | 53.3 | <0.0001 |
| HAV | 8859 | 398 | 24628.67 | 1.62 | 1.45 | 1.79 | - | - | - | - | |
| HPV-33 | HPV | 8856 | 159 | 24956.13 | 0.64 | 0.54 | 0.75 | 26.3 | 8.2 | 41.0 | 0.0034 |
| HAV | 8859 | 216 | 24972.12 | 0.86 | 0.75 | 1.00 | - | - | - | - | |
| HPV-35 | HPV | 8856 | 117 | 25068.97 | 0.47 | 0.38 | 0.56 | -22.4 | -64.5 | 8.6 | 0.1484 |
| HAV | 8859 | 96 | 25184.28 | 0.38 | 0.31 | 0.47 | - | - | - | - | |
| HPV-39 | HPV | 8856 | 309 | 24705.31 | 1.25 | 1.11 | 1.41 | -0.6 | -19.2 | 15.1 | 0.9673 |
| HAV | 8859 | 308 | 24778.10 | 1.24 | 1.10 | 1.40 | - | - | - | - | |
| HPV-45 | HPV | 8856 | 69 | 25150.80 | 0.27 | 0.21 | 0.35 | 56.4 | 40.9 | 68.1 | <0.0001 |
| HAV | 8859 | 158 | 25114.37 | 0.63 | 0.53 | 0.74 | - | - | - | - | |
| HPV-51 | HPV | 8856 | 582 | 24187.62 | 2.41 | 2.20 | 2.62 | 12.1 | 1.0 | 21.9 | 0.0234 |
| HAV | 8859 | 660 | 24118.36 | 2.74 | 2.52 | 2.97 | - | - | - | - | |
| HPV-52 | HPV | 8856 | 604 | 24142.72 | 2.50 | 2.30 | 2.72 | 7.8 | -3.8 | 18.0 | 0.1437 |
| HAV | 8859 | 655 | 24152.33 | 2.71 | 2.50 | 2.94 | - | - | - | - | |
| HPV-56 | HPV | 8856 | 304 | 24733.27 | 1.23 | 1.09 | 1.38 | 2.0 | -16.1 | 17.3 | 0.8055 |
| HAV | 8859 | 311 | 24799.99 | 1.25 | 1.11 | 1.41 | - | - | - | - | |
| HPV-58 | HPV | 8856 | 248 | 24855.89 | 1.00 | 0.87 | 1.14 | -2.0 | -23.4 | 15.7 | 0.8550 |
| HAV | 8859 | 244 | 24938.21 | 0.98 | 0.85 | 1.12 | - | - | - | - | |
| HPV-59 | HPV | 8856 | 160 | 25037.57 | 0.64 | 0.54 | 0.75 | 2.8 | -23.0 | 23.2 | 0.8228 |
| HAV | 8859 | 165 | 25098.33 | 0.66 | 0.56 | 0.77 | - | - | - | - | |
| HPV-66 | HPV | 8856 | 295 | 24741.94 | 1.19 | 1.05 | 1.34 | 7.1 | -10.1 | 21.6 | 0.3658 |
| HAV | 8859 | 318 | 24782.75 | 1.28 | 1.14 | 1.44 | - | - | - | - | |
| HPV-68 | HPV | 8856 | 256 | 24823.38 | 1.03 | 0.90 | 1.17 | 0.9 | -19.4 | 17.7 | 0.9287 |
| HAV | 8859 | 259 | 24900.76 | 1.04 | 0.91 | 1.18 | - | - | - | - | |
| HPV-HRW | HPV | 8856 | 2184 | 20788.77 | 10.51 | 10.05 | 10.98 | 10.4 | 4.7 | 15.7 | 0.0001 |
| HAV | 8859 | 2407 | 20529.82 | 11.72 | 11.24 | 12.23 | - | - | - | - | |
| HPV-HR | HPV | 8856 | 2401 | 20113.13 | 11.94 | 11.44 | 12.45 | 17.4 | 12.4 | 22.0 | <0.0001 |
| HAV | 8859 | 2821 | 19532.02 | 14.44 | 13.89 | 15.02 | - | - | - | - | |
HPV = HPV-16/18 L1 VLP AS04 vaccine (three lots) = Vaccine group
HAV = Hepatitis A vaccine (three lots) = Control group
N=number of subjects included in each group
Follow-up period starts at first visit
Subjects have at least 5 months of follow-up after first visit
n=number of subjects reporting at least one event in each group
HPV-HRW = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18
HPV-HR = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
T(years)=sum of follow-up period (censored at the first occurrence of an event) expressed in years in each group
n/T=Incidence rate of subjects reporting at least one event
VE(%)=Vaccine Efficacy (conditional exact method)
LL,UL=96.1% Lower and Upper confidence limits
P-value=Two-sided Fisher Exact test
