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

NCT04206813 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2026-04-29

No results posted yet for this 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

Interventions

DRUG

Gardasil 9 2 dose regimen

a 2-dose regimen of Gardasil 9 at 0 and 6 months

DRUG

Gardasil 9 3 dose regimen

standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months

DRUG

Gardasil 9 rescue dose

A rescue dose of Gardasil 9 will be given at 12 months

Sponsors & Collaborators

Principal Investigators

  • Carl G Streed, MD MPH · Boston Medical Center, Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2026-04-15
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206813 on ClinicalTrials.gov