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NCT03451071 · ClinicalTrials.gov registry record · Phase 4

Postpartum HPV Vaccination

A Phase 4 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 4
Development phase
195
Enrollment target

NCT03451071 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 195 participants.

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The verdict

NCT03451071, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 4
Development phase
195 participants
Enrollment target

Study 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.

Interventions

  • DRUG Gardasil9

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2019-04-29
Est. Completion 2020-12-30
Phase Phase 4

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03451071

The ClinicalTrials.gov registry entry for NCT03451071 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Gardasil9 is the first listed.

NCT03451071 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03451071 about?

NCT03451071 is a clinical study titled "Postpartum HPV Vaccination". 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, inn...

What is the current status of trial NCT03451071?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 195 participants. The study started on 2019-04-29. Estimated completion is 2020-12-30.

What interventions are being tested in trial NCT03451071?

The interventions under investigation include: Gardasil9 (DRUG).

Who is sponsoring clinical trial NCT03451071?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.