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. 2020 Mar 17;25(6):213–219. doi: 10.1136/bmjebm-2019-111331

Table 3.

Ingredients of control arm, by trial document type

Trial Clinical study report Informed consent form Register Publication
V501-012 225 mcg of aluminium as AAHS in normal saline Inactive solution (containing aluminium 225 mcg/dose) Control intervention not listed Aluminium-containing placebo
V501-013 225 mcg of aluminium as AAHS in normal saline Inactive solution (containing aluminium 225 mcg/dose) No ingredients listed; only states ‘placebo’ Aluminium-containing placebo
V501-015 225 mcg of aluminium as AAHS in normal saline Inactive solution (containing aluminium 225 mcg/dose) No ingredients listed; only states ‘placebo’ Aluminium-containing placebo
V501-019 Merck standard aluminium diluent (225 mcg alum) in normal saline No ingredients listed. Only states: ‘The HPV vaccine placebo contains no active vaccine’ No ingredients listed; only states ‘placebo’ Aluminium-containing placebo
V501-020 225 mcg of aluminium as AAHS in normal saline No ingredients listed. Only states: ‘placebo, an injection that looks the same as the vaccine but has no active ingredient’ No ingredients listed; only states ‘placebo’ AAHS-containing placebo

Normal saline = USP (NaCl 0.9%).

AAHS, amorphous aluminum hydroxyphosphate sulfate.