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HPV Vaccination Study in Postpartum Women

NCT04274153 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2023-08-29

Study results available
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Summary

The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.

Conditions

Interventions

BIOLOGICAL

Gardasil9

Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Sponsors & Collaborators

Principal Investigators

  • Jenell Coleman, MD · Johns Hopkins University

  • Chailee Moss, MD · Johns Hopkins University

  • Betty Chou, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2022-07-01
Completion
2023-02-01
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 NCT04274153 on ClinicalTrials.gov