Exhibit 005

Gardasil 9 prescribing information, clinical studies

Exhibit 005 · Product label

Gardasil 9 prescribing information, clinical studies

The pivotal efficacy trial (Study 1, 14,204 women) was an active comparator-controlled, double-blind, randomized clinical trial against Gardasil. The label also reports Study 4, a safety study in which 608 participants received Gardasil 9 and 305 received saline placebo; all had previously received three doses of Gardasil.

Source: Merck Sharp & Dohme / U.S. Food and Drug Administration
Date: 2014 onward
Grade: Primary record
Document: https://www.fda.gov/media/90064/download
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Cited by

Finding MED-3.3: Reported The pivotal trials of the Gardasil vaccines were not compared with an inert placebo. According to ICAN's 2018 reply to HHS, most other vaccines on the current childhood schedule were also licensed against other vaccines or adjuvant-containing controls.