This document summarises evidence from studies included in the licensing file of HPV vaccines together with postlicensure, peer-reviewed data and analysis where available. This guidance does not address the safety of HPV vaccines observed during the pre- and post-licensing period.
A double-blind, placebo-controlled, dose-escalation, phase 1 study was performed in 60 healthy subjects between 18 and 49 years of age. The two-dose regimen induced the development of neutralizing antibodies in high percentages of the subjects (from 88% to 100% of subjects depending on antigen content)”.