An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

NCT Number	NCT04206813
Lead Sponsor	Boston Medical Center Collaborators: Merck Sharp & Dohme LLC
Conditions	HPV Infection
Enrollment	352 participants
Start Date	2020-12-01
Primary Completion	2026-04-15 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-29