Trial intelligence / Profile preview

GARDASIL 9 in Post Solid Organ Transplant Patients

NCT05557370Phase 4

Key facts

Status
Active, not recruiting
Start
Jun 2023
Primary completion
Dec 2028
Countries
1
Sponsor
Medical College of Wisconsin
Modality
Vaccines & Immunotherapeutics
Conditions
human papillomavirus infection
01

Overview

Phase 4, open-label, single-arm trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection, sponsored by Medical College of Wisconsin. Primary endpoint: Geometric Mean Titers of Anti-HPV antibodies at 24 months. Started Jun 2023; status: active, not recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Interventional

    Patients receive 3-dose 9vHPV vaccination (GARDASIL 9)

03

Who it enrols

Adults 18-45 years old, at least 6 months post-solid-organ transplant, who have not received GARDASIL 9.

04

Endpoints

Primary

  • Geometric Mean Titers of Anti-HPV antibodies

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