At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 271 enrolled
Drug / intervention
9-valent HPV vaccinebiological
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.
An Open-label Phase III Study to Investigate the Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine (Gardasil®9) in Solid Organ Transplant Recipients and HIV-infected Patients
In Brief
A Phase 3 clinical trial evaluating 9-valent HPV vaccine for Human Papilloma Virus and 2 related conditions. Completed, enrolled 271 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Papilloma Virus, Hiv, Organ Transplants
CountriesBelgium
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
First PostedMay 2018
Primary CompletionSep 2019
Study CompletionJul 2020
TodayJul 2026
First PostedMay 15, 2018
Enrollment StartApr 4, 2018
Primary CompletionSep 1, 2019
Study CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.1 years ago
Interventions
9-valent HPV vaccinebiological
Vaccination