CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 195 enrolled
Drug / intervention
Gardasil9drug
Likely dose
Not stated in 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/NCT03451071
NCT03451071Phase 4Completed

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

University of Alabama at Birmingham·interventional·Posted Mar 1, 2018·Updated Oct 4, 2021

In Brief

A Phase 4 clinical trial evaluating Gardasil9 for HPV-Related Malignancy. Completed, enrolled 195 participants across 1 site.

Detailed Summary

Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartApr 29, 2019
Primary CompletionJun 1, 2020
Study CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.3 years ago

Interventions

Gardasil9drug

Gardasil 9