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NCT00339040 · ClinicalTrials.gov registry record · Phase 2
Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
A Phase 2 study of HIV Infections and Sexually Transmitted Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT00339040: Completed Phase 2 study of HIV Infections and Sexually Transmitted Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00339040 is a Phase 2 study of HIV Infections and Sexually Transmitted Diseases that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 130 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00339040, a Phase 2 study of HIV Infections and Sexually Transmitted Diseases, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
Conditions Studied
Interventions
- BIOLOGICAL Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
- OTHER Placebo/QHPV
Study Locations (20)
California
- Usc La Nichd Crs - Alhambra
- Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- Children's Hosp. of Orange County - Orange
- UCSD Mother-Child-Adolescent Program CRS - San Diego
- Univ. of California San Francisco NICHD CRS - San Francisco
Florida
- South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami
Illinois
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program - Chicago
- Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
- Chicago Children's CRS - Chicago
Massachusetts
- Children's Hosp. of Boston NICHD CRS - Boston
- Boston Medical Center Ped. HIV Program NICHD CRS - Boston
- WNE Maternal Pediatric Adolescent AIDS CRS - Worcester
District of Columbia
- Children's National Med. Ctr. Washington DC NICHD CRS - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
Connecticut
- Connecticut Children's Med. Ctr. - Hartford
Louisiana
- Children's Hosp. - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00339040 record still lists
NCT00339040 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) is the first listed.
NCT00339040 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00339040 about?
NCT00339040 is a clinical study titled "Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children". 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.
What is the current status of trial NCT00339040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2006-10. Estimated completion is 2009-08.
What conditions does trial NCT00339040 study?
This clinical trial studies the following conditions: HIV Infections, Sexually Transmitted Diseases.
What interventions are being tested in trial NCT00339040?
The interventions under investigation include: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) (BIOLOGICAL), Placebo/QHPV (OTHER).
Who is sponsoring clinical trial NCT00339040?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00339040 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00339040's enrollment target sits among peer trials
130 227th of 542 higher than 313 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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