Table 3. Women with evidence of prior exposure evaluated for vaccine efficacy.
Lehtinen et al (2012)[19] | The FUTURE II Study Group (2007a)[1] | Castellsagué et al 2011[15] | Joura et al (2007)[20] | Olsson et al (2009)[14] | |
TVC * included: | Combination of women enrolled in the TVC** of four individual trials:[12], [21]–[23] | Combination of women enrolled in the TVC** of three individual trials:[12], [21], [23] | Sub-population of 2617 women from three individual trials who were seropositive and DNA-negative to one or more vaccine HPV type(s) at day 1.[12], [21], [23] | ||
HPV-naïve | ¶ | ¶ | ¶ | ¶ | |
Evidence of exposure to any high-risk or low-risk HPV type | ¶ | ¶ | ¶ | ¶ | |
Abnormal cervical cytology | ¶ | ¶ | ¶ | ||
Prevalent cervical disease | ¶ | ||||
Prevalent anogenital disease | ¶ | ||||
TVC-naïve included: | Combination of women enrolled in the TVC-naïve of four individual trials:[12], [21]–[23] | Combination of women enrolled in the TVC-naïve of three individual trials:[12], [21], [23] | |||
HPV-naïve | ¶ | ¶ | ¶ | ||
Evidence of current exposure to any low-risk HPV type | ¶ | ||||
Evidence of past exposure to any non-vaccine HPV type | ¶ | ||||
Evidence of exposure to any non-vaccine HPV type | ¶ | ¶ | |||
Abnormal cervical cytology | ¶ | ¶ | |||
NRT for HPV-16/18 related outcomes included: | |||||
HPV-naïve | ¶ | ||||
Evidence of exposure to vaccine types 6/11 and any non-vaccine HPV type | ¶ | ||||
Derived sub-group of exposed women included: | |||||
HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 DNA+ (and potentially sero+) or HPV-16/18 sero+ | ¶ | ||||
HPV-6/11/16/18 DNA+ and/or sero+ | ¶ | ¶ | |||
HPV-16/18 DNA+ and/or sero+ | ¶ | ||||
Abnormal cervical cytology | ¶ | ||||
Prevalent cervical disease | ¶ | ||||
Prevalent anogenital disease | ¶ | ||||
Number of women in derived sub-group: | 6484 | 1117 | 143 | 643 |
*Women with a history of genital warts or warts at baseline were not included in the TVC.
**A TVC was not investigated in one individual RCT.[21] Outcomes for a TVC in this report were derived from the summary of participants excluded from analysis, extracting data specifically on women excluded from the TVC-naïve.