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An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
Sponsor: Boston Medical Center
Summary
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.
Official title: An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study
Key Details
Gender
FEMALE
Age Range
16 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2020-12-01
Completion Date
2026-06
Last Updated
2026-01-27
Healthy Volunteers
Yes
Conditions
Interventions
Gardasil 9 2 dose regimen
a 2-dose regimen of Gardasil 9 at 0 and 6 months
Gardasil 9 3 dose regimen
standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
Gardasil 9 rescue dose
A rescue dose of Gardasil 9 will be given at 12 months
Locations (1)
Boston Medical Center
Boston, Massachusetts, United States