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NCT04206813 · ClinicalTrials.gov registry record · Phase 4
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
A Phase 4 study of HPV Infection, sponsored by Boston Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 352
- Enrollment target
- 1
- Study location
NCT04206813: Active Phase 4 study of HPV Infection, sponsored by Boston Medical Center.
NCT04206813 is a Phase 4 study of HPV Infection that is active but no longer recruiting, run by Boston Medical Center. The registered enrollment target is 352 participants, above the 209-participant average among 13 other HPV Infection trials with a reported enrollment target (68% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04206813, a Phase 4 study of HPV Infection, is active but no longer recruiting, sponsored by Boston Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 352 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Immunogenicity will be measured by serum antibodies assessed by ELISA to the nine HPV types (anti-HPV 6/11/16/18/31/33/45/ 52/58 where positive anti-HPV serum levels are defined as \>30, \>16, \>20, \>24, \>10, \>8, \>8, \>8, or \>8 milli Merck units (mMU)/mL respectively).
Conditions Studied
Interventions
- DRUG Gardasil 9 2 dose regimen
- DRUG Gardasil 9 3 dose regimen
- DRUG Gardasil 9 rescue dose
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
What the registry record for NCT04206813 still lists
NCT04206813 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, above the 209-participant average among 13 other HPV Infection trials with a reported enrollment target (68% higher).
The record links to 1 condition, with HPV Infection appearing as the primary indexed condition, and to 3 interventions - of which Gardasil 9 2 dose regimen is the first listed.
NCT04206813 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04206813 about?
NCT04206813 is a clinical study titled "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 ye...
What is the current status of trial NCT04206813?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 352 participants. The study started on 2020-12-01. Estimated completion is 2026-06.
What conditions does trial NCT04206813 study?
This clinical trial studies the following conditions: HPV Infection.
What interventions are being tested in trial NCT04206813?
The interventions under investigation include: Gardasil 9 2 dose regimen (DRUG), Gardasil 9 3 dose regimen (DRUG), Gardasil 9 rescue dose (DRUG).
Who is sponsoring clinical trial NCT04206813?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04206813 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04206813's enrollment target sits among peer trials
352 4th of 13 higher than 10 of 13 other HPV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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