MedTrace Logo

Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

NCT03525210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2020-12-11

Study results available
· View outcomes & findings →

Summary

Patients with immunodeficiencies are at increased risk of developing persistent HPV infection and as such HPV-related disease (genital warts and cancer).

In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety, tolerability and immunogenicity will be evaluated up to one month following the 3rd and last dose of Gardasil®9.

Conditions

Interventions

BIOLOGICAL

9-valent HPV vaccine

Vaccination

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Corinne Vandermeulen, MD, PhD · UZ Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2019-09-01
Completion
2020-07-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT03525210 on ClinicalTrials.gov