Statistical Data Analysis Plan Efficacy Merck's HPV Vaccine (Studies 005, 007, 013, and 015) - Amendment 1 - August 2005

2005_FDA_r_s_F11-7942 DAP-Efficacy-Studies-005-007-013-015

We obtained Gardasil® Data Analysis Plans (DAPs) from the FDA through Freedom of Information Act (FOIA) request. The above linked DAP introduced modifications in the study participants populations. Instead of “per protocol analysis” for the outcome CIN 2+ irrespective of HPV type, this DAP introduced a post-hoc subgroup analysis (subgroup of subjects negatives to 14 HPV types, called RMITT-2).