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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 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.

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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.

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

FieldValue
Enrollment Target 352 participants
Start Date 2020-12-01
Est. Completion 2026-06
Phase Phase 4

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT04206813

The ClinicalTrials.gov registry entry for NCT04206813 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 209-participant average among 13 other HPV Infection trials with a reported enrollment target (68% higher). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.