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Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
NCT00459316 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00459316 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00459316?
The interventions under investigation include: Quadrivalent meningococcal conjugate vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00459316?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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