CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) +1 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/NCT00339040
NCT00339040Phase 2Completed
CompareCT.gov

Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in HIV Infected Children 7 to 12 Years of Age

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 20, 2006·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) and Placebo/QHPV for HIV Infections and Sexually Transmitted Diseases. Completed, enrolled 130 participants across 34 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Sexually Transmitted Diseases
CountriesPuerto Rico, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.0 years ago

Interventions

Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)biological

QHPV at week 0, 8, 24 and 96.

Placebo/QHPVother

Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.