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Vaccines

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 TypeGroupNnT(year)n/T
(Per 100)
LLUL%LLULP-value
HPV-16HPV862526124477.951.070.931.2147.438.255.2<0.0001
 HAV864848924147.922.031.842.22----
HPV-18HPV86258324953.400.330.260.4251.635.963.7<0.0001
 HAV864817124890.150.690.580.80----
HPV-31HPV862513524839.360.540.450.6538.522.551.3<0.0001
 HAV864821924799.650.880.761.01----
HPV-33HPV86258025000.950.320.250.4025.8-1.546.00.0475
 HAV864810825030.930.430.350.53----
HPV-35HPV86255825056.510.230.170.30-35.4-110.312.10.1355
 HAV86484325154.580.170.120.23----
HPV-39HPV862514024868.760.560.470.670.4-28.422.71.0000
 HAV864814124949.240.570.470.67----
HPV-45HPV86254025082.430.160.110.2236.41.959.20.0292
 HAV86486325136.750.250.190.32----
HPV-51HPV862524524635.270.990.871.1319.02.932.40.0149
 HAV864830224609.961.231.091.38----
HPV-52HPV862532524475.011.331.181.491.8-15.716.70.8115
 HAV864833224549.271.351.201.51----
HPV-56HPV862511324941.490.450.370.559.4-19.431.30.4729
 HAV864812524989.600.500.410.60----
HPV-58HPV862512724924.850.510.420.61-20.4-59.68.90.1663
 HAV864810625054.360.420.340.52----
HPV-59HPV86255525075.020.220.160.29-25.5-95.118.80.2693
 HAV86484425170.710.170.120.24----
HPV-66HPV862511724935.450.470.380.57-3.0-36.322.20.8427
 HAV864811425019.090.460.370.55----
HPV-68HPV862510424951.420.420.340.512.5-30.827.30.8899
 HAV864810725035.650.430.350.52----
HPV-HRWHPV8625121122457.925.395.085.729.61.816.80.0113
 HAV8648133322341.335.975.636.31----
HPV-HRHPV8625141421883.106.466.116.8317.511.123.5<0.0001
 HAV8648168321481.167.837.458.24----

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 TypeGroupNnT(year)n/T
(Per 100)
LLUL%LLULP-value
HPV-16HPV885639024273.941.611.441.7855.249.160.6<0.0001
 HAV885984823631.273.593.343.85----
HPV-18HPV885614124932.960.570.470.6763.054.570.1<0.0001
 HAV885937724659.971.531.371.70----
HPV-31HPV885622324764.900.900.781.0344.333.653.3<0.0001
 HAV885939824628.671.621.451.79----
HPV-33HPV885615924956.130.640.540.7526.38.241.00.0034
 HAV885921624972.120.860.751.00----
HPV-35HPV885611725068.970.470.380.56-22.4-64.58.60.1484
 HAV88599625184.280.380.310.47----
HPV-39HPV885630924705.311.251.111.41-0.6-19.215.10.9673
 HAV885930824778.101.241.101.40----
HPV-45HPV88566925150.800.270.210.3556.440.968.1<0.0001
 HAV885915825114.370.630.530.74----
HPV-51HPV885658224187.622.412.202.6212.11.021.90.0234
 HAV885966024118.362.742.522.97----
HPV-52HPV885660424142.722.502.302.727.8-3.818.00.1437
 HAV885965524152.332.712.502.94----
HPV-56HPV885630424733.271.231.091.382.0-16.117.30.8055
 HAV885931124799.991.251.111.41----
HPV-58HPV885624824855.891.000.871.14-2.0-23.415.70.8550
 HAV885924424938.210.980.851.12----
HPV-59HPV885616025037.570.640.540.752.8-23.023.20.8228
 HAV885916525098.330.660.560.77----
HPV-66HPV885629524741.941.191.051.347.1-10.121.60.3658
 HAV885931824782.751.281.141.44----
HPV-68HPV885625624823.381.030.901.170.9-19.417.70.9287
 HAV885925924900.761.040.911.18----
HPV-HRWHPV8856218420788.7710.5110.0510.9810.44.715.70.0001
 HAV8859240720529.8211.7211.2412.23----
HPV-HRHPV8856240120113.1311.9411.4412.4517.412.422.0<0.0001
 HAV8859282119532.0214.4413.8915.02----

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