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NCT04206813Active, not recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
352 (actual)
First submitted
15 Dec 2019
Start date
1 Dec 2020
Primary completion date
15 Apr 2026
Lead sponsor
Boston Medical Center
NCT number
NCT04206813

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 352
  • From 1 Dec 2020 to the primary completion date, 15 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior HPV vaccination
  • Immunocompromised/previous immunosuppressive therapy

Other illness

  • A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
  • Thrombocytopenia or other coagulation disorder

Other

  • Currently pregnant
  • Currently breastfeeding

Who the study is looking for

  • Women receiving care at Boston Medical Center

Age in the registry: 16 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.