The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Exhibit 006

Gardasil prescribing information, clinical studies

Exhibit 006 · Product label

Gardasil prescribing information, clinical studies

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled)

Most control recipients in the licensure trials received a "placebo" containing the vaccine’s aluminum adjuvant (amorphous aluminum hydroxyphosphate sulfate). A smaller group received a non-aluminum placebo.

Source
Merck Sharp & Dohme / U.S. Food and Drug Administration
Date
2006 onward
Quoted from
Package insert, section 6.1 Clinical Trials Experience (revision 04/2015, p. 3-4); same section: AAHS control N = 13,023, saline placebo N = 594
Grade
Primary record
Document
https://www.fda.gov/media/74350/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.