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NCT00992017 · ClinicalTrials.gov registry record · Phase 2
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
A Phase 2 study of HIV Infections and H1N1 Influenza Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT00992017 is a Phase 2 study of HIV Infections and H1N1 Influenza Virus 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 10 states.
The verdict
NCT00992017, a Phase 2 study of HIV Infections and H1N1 Influenza Virus, 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
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.
Conditions Studied
Interventions
- BIOLOGICAL Influenza A (H1N1) monovalent vaccine
Study Locations (20)
California
- Usc La Nichd Crs - Alhambra
- University of California, UC San Diego CRS - La Jolla
- Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- 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
- Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami
- USF - Tampa NICHD CRS - Tampa
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
Illinois
- Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
- Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS - Chicago
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
District of Columbia
- Washington Hosp. Ctr. NICHD CRS - Washington D.C.
Louisiana
- Tulane Univ. New Orleans NICHD CRS - New Orleans
Maryland
- Johns Hopkins Univ. Baltimore NICHD CRS - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00992017
The ClinicalTrials.gov registry entry for NCT00992017 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% 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 Influenza A (H1N1) monovalent vaccine is the first listed.
NCT00992017 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00992017 about?
NCT00992017 is a clinical study titled "Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women". Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza va...
What is the current status of trial NCT00992017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2009-10. Estimated completion is 2010-11.
What conditions does trial NCT00992017 study?
This clinical trial studies the following conditions: HIV Infections, H1N1 Influenza Virus.
What interventions are being tested in trial NCT00992017?
The interventions under investigation include: Influenza A (H1N1) monovalent vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00992017?
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 NCT00992017 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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