CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,499 enrolled
Drug / intervention
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) +3 morebiological
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/NCT01492582
NCT01492582Phase 2Completed
CompareCT.gov

Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

University of Alabama at Birmingham·interventional·Posted Dec 15, 2011·Updated Oct 27, 2021

In Brief

A Phase 2 clinical trial evaluating quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), laboratory biomarker analysis, and 2 other interventions for Cancer Survivor and Prevention of Human Papillomavirus Infection. Completed, enrolled 1,499 participants across 5 sites.

Detailed Summary

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer Survivor, Prevention of Human Papillomavirus Infection
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2011
Enrollment StartJul 1, 2012
Primary CompletionFeb 8, 2019
Study CompletionJul 20, 2020
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 14.5 years ago

Interventions

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)biological

Given IM

laboratory biomarker analysisother

Correlative studies

survey administrationother

Ancillary studies

medical chart reviewother

Ancillary studies