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GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose

NCT03943875 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 767

Last updated 2026-04-16

Study results available
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Summary

The investigators are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.

Conditions

Interventions

BIOLOGICAL

9-valent HPV vaccine, 2 dose efficacy

Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.

BIOLOGICAL

9-valent HPV vaccine, 3 doses standard timing

Will be comparison group for 2 dose efficacy group.

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Abbey B Berenson, MD, PhD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2025-01-13
Completion
2025-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03943875 on ClinicalTrials.gov