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NCT00459316 · ClinicalTrials.gov registry record · Phase 1
Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
A Phase 1 study of HIV Infections and Meningitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 384
- Enrollment target
- 20
- Study locations
NCT00459316 is a Phase 1 study of HIV Infections and Meningitis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 384 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00459316, a Phase 1 study of HIV Infections and Meningitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 384 participants
- Enrollment target
- 20
- Study locations
Study Summary
Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especially for HIV-infected youth who have weakened immune systems. The purpose of this study was to determine the safety of and immune response to a preventive meningitis vaccine in HIV-infected youth.
Conditions Studied
Interventions
- BIOLOGICAL Quadrivalent meningococcal conjugate vaccine
Study Locations (20)
California
- Usc La Nichd Crs - Alhambra
- Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
- Children's Hospital of Los Angeles NICHD CRS - Los Angeles
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- University of California, UC San Diego CRS - San Diego
- Univ. of California San Francisco NICHD CRS - San Francisco
- Harbor UCLA Medical Ctr. NICHD CRS - Torrance
Florida
- South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
- Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami
- USF - Tampa NICHD CRS - Tampa
District of Columbia
- Children's National Med. Ctr. Washington DC NICHD CRS - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Illinois
- Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
- Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS - Chicago
Massachusetts
- Children's Hosp. of Boston NICHD CRS - Boston
- Boston Medical Center Ped. HIV Program NICHD CRS - Boston
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
Louisiana
- Tulane Univ. New Orleans NICHD CRS - New Orleans
Maryland
- Univ. of Maryland Baltimore NICHD CRS - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00459316
The ClinicalTrials.gov registry entry for NCT00459316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (14% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Quadrivalent meningococcal conjugate vaccine is the first listed.
NCT00459316 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00459316 about?
NCT00459316 is a clinical study titled "Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth". Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especi...
What is the current status of trial NCT00459316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 384 participants. The study started on 2007-06. Estimated completion is 2013-03.
What conditions does trial NCT00459316 study?
This clinical trial studies the following conditions: HIV Infections, Meningitis.
What interventions are being tested in trial NCT00459316?
The interventions under investigation include: Quadrivalent meningococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00459316?
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 NCT00459316 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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