Skip to main content
. 2020 Mar 17;25(6):213–219. doi: 10.1136/bmjebm-2019-111331

Table 5.

Injection-site adverse experiences between Gardasil and control arms

Trial Gardasil Control Difference Source
V501-012 87.9% 78.6% (with AAHS) 9.3% CSR p.33
V501-013 88.0% 79.8% (with AAHS) 8.2% CSR p.13
V501-015* 84.4% 77.9% (with AAHS) 6.5% Publication table 4
V501-019 76.7% 64.2% (with AAHS) 12.5% CSR p.566
V501-020 60.1% 53.7% (with AAHS) 6.4% CSR p.348
V501-018 75.3% 50.0% (without AAHS) 25.3% CSR p.33

*The CSR for V501-015 reports injection-site adverse experiences as 8.8% (qHPV) versus 7.6% (control), but these figures are likely an underestimate as injection-site adverse experiences were only collected for participants in the Non-Serious Adverse Experience Substudy, and data for this subpopulation were reported in the publication but not CSR.

AAHS, amorphous aluminium hydroxyphosphate sulfate; CSR, clinical study reports.