Table 4

Rationale for aluminium-containing control (verbatim quotes)

TrialPublications, registers, study protocols, ICFs, and CSR synopsesClinical study reports (CSR main body)
V501-012None provided‘Aluminum adjuvant was chosen as the appropriate control for the qHPV vaccine for the following reasons:

  1. The inclusion of aluminum adjuvant in both vaccine and placebo preserved the blinding of the study because it allowed the vaccine and placebo to be visually indistinguishable; and

  2. The safety profile of Merck’s aluminum adjuvant is well characterised. On the other hand, the safety profile of the HPV 6, 11, 16 and 18 L1 VLPs required further evaluation in humans. By using placebo that contained a dose of aluminum adjuvant that was identical to the dose included in the qHPV vaccine, it was possible to assess the safety profile attributable to the HPV 6, 11, 16 and 18 L1 VLP component of the vaccine.’

V501-013None provided
V501-015None provided
V501-019None providedNone provided
V501-020None providedNone provided

  • Normal saline = USP (NaCl 0.9%).

  • CSR, clinical study report; ICF, informed consent form; qHPV, quadrivalent human papillomavirus; VLP, virus-like particle.