Vaccines, Blood & Biologics
Table 97TVC - Cervarix, August 11, 2009
Table 97TVC Summary table of vaccine efficacy against virological endpoints associated with specific oncogenic HPV types (by PCR) in HPV DNA negative subjects using conditional exact method (TVC irrespective of baseline)
| TVC irrespective of baseline | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Event Type | 6-month persistent infection | 12-month persistent infection | ||||||||
n* | % | LL | UL | P-value | n* | % | LL | UL | P-value | |
| HPV-31 | 223/398 | 44.3 | 33.6 | 53.3 | <0.0001 | 135/219 | 38.5 | 22.5 | 51.3 | <0.0001 |
| HPV-33 | 159/216 | 26.3 | 8.2 | 41.0 | 0.0034 | 80/108 | 25.8 | -1.5 | 46.0 | 0.0475 |
| HPV-35 | 117/96 | -22.4 | -64.5 | 8.6 | 0.1484 | 58/43 | -35.4 | -110.3 | 12.1 | 0.1355 |
| HPV-45 | 69/158 | 56.4 | 40.9 | 68.1 | <0.0001 | 40/63 | 36.4 | 1.9 | 59.2 | 0.0292 |
| HPV-51 | 582/660 | 12.1 | 1.0 | 21.9 | 0.0234 | 245/302 | 19.0 | 2.9 | 32.4 | 0.0149 |
| HPV-58 | 248/244 | -2.0 | -23.4 | 15.7 | 0.8550 | 127/106 | -20.4 | -59.6 | 8.9 | 0.1663 |
| HPV-68 | 256/259 | 0.9 | -19.4 | 17.7 | 0.9287 | 104/107 | 2.5 | -30.8 | 27.3 | 0.8899 |
* n=number of subjects reporting at least one event in each group (HPV group/HAV group).
Note: Similar list of oncogenic HPV types of Table 97 (page 355) of the Clinical report have been retained.
For all subjects, follow-up period starts at first visit
For 12 Month persistent, subjects have at least 10 months of follow-up after first visit
For 6 Month persistent, subjects have at least 5 months of follow-up after first visit
VE (%) = Vaccine Efficacy (Conditional Method)
LL, UL = 96.1% Lower and Upper confidence limits, P-value = Two-sided Fisher Exact test
