CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 225 enrolled
Drug / intervention
Gardasil9biological
Likely dose
Gardasil9 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04274153
NCT04274153Phase 4Completed

A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV

Johns Hopkins University·interventional·Posted Feb 18, 2020·Updated Aug 29, 2023

In Brief

A Phase 4 clinical trial evaluating Gardasil9 for HPV and 2 related conditions. Completed, enrolled 225 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 18, 2020
Enrollment StartAug 3, 2020
Primary CompletionJul 1, 2022
Study CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.4 years ago

Interventions

Gardasil9biological

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