Table 5

Injection-site adverse experiences between Gardasil and control arms

V501-01287.9%78.6% (with AAHS)9.3%CSR p.33
V501-01388.0%79.8% (with AAHS)8.2%CSR p.13
V501-015*84.4%77.9% (with AAHS)6.5%Publication table 4
V501-01976.7%64.2% (with AAHS)12.5%CSR p.566
V501-02060.1%53.7% (with AAHS)6.4%CSR p.348
V501-01875.3%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.