Other Open Access

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

Lisa Lupinacci

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).

Files (2.8 MB)
Name Size
2005_FDA_r_s_F11-7942 DAP-Efficacy-Studies-005-007-013-015.pdf
md5:85c1aac9e132a3ed036be977268f7a88
2.8 MB Download
308
82
views
downloads
All versions This version
Views 308308
Downloads 8282
Data volume 230.4 MB230.4 MB
Unique views 285285
Unique downloads 7474

Share

Cite as