An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen (NCT04206813)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (7 items).
Location: Boston Medical Center — Boston, Massachusetts
Age range: 16 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Currently pregnant
- Prior HPV vaccination
- A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
- Immunocompromised/previous immunosuppressive therapy
- Thrombocytopenia or other coagulation disorder
- Currently breastfeeding
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Boston Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HPV Infection
- Feasibility of HPV Testing With Mail-delivered Sample Collection Kits — San Francisco, California
- Intradermal, Fractional Dose of HPV Vaccines: — Seattle, Washington
- Immunogenicity of Fractional Dose of the HPV Vaccines — Seattle, Washington
- PCOM2 - The Physician Communication Intervention, Version 2.0 — Aurora, Colorado
- Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer — New Haven, Connecticut
Explore by condition: All HPV Infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.