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Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

NCT00339040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-11-05

Study results available
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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.

Conditions

  • HIV Infections
  • Sexually Transmitted Diseases

Interventions

BIOLOGICAL

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

QHPV at week 0, 8, 24 and 96.

OTHER

Placebo/QHPV

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Myron J. Levin, MD · Pediatric Infectious Diseases Section, University of Colorado Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT00339040 on ClinicalTrials.gov