Statistical Data Analysis Plan Efficacy Merck'S Hpv Vaccine (Studies 005, 007, 013, And 015) - Amendment 1 - August 2005

Name: Statistical Data Analysis Plan Efficacy Merck'S Hpv Vaccine (Studies 005, 007, 013, And 015) - Amendment 1 - August 2005
Creator: Lupinacci, Lisa
Keywords: Gardasil, HPV Vaccine, Approval, Data Analysis Plan, 3. Good health

Lupinacci, Lisa

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Other ORP type . 2005

License: CC BY

Data sources: Datacite

ZENODO

Other ORP type . 2005

License: CC BY

Data sources: Datacite

Statistical Data Analysis Plan Efficacy Merck'S Hpv Vaccine (Studies 005, 007, 013, And 015) - Amendment 1 - August 2005

appsOther research productkeyboard_double_arrow_right Other ORP type 04 Aug 2005 English Publisher:Zenodo

Authors: Lupinacci, Lisa;

doi: 10.5281/zenodo.1434219 , 10.5281/zenodo.1434220

Statistical Data Analysis Plan Efficacy Merck'S Hpv Vaccine (Studies 005, 007, 013, And 015) - Amendment 1 - August 2005

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Abstract

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).

Keywords

Gardasil, HPV Vaccine, Approval, Data Analysis Plan

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