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NCT00905125 · ClinicalTrials.gov registry record · Phase 2
Influenza Vaccine in Pregnant Women
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 9
- Study locations
NCT00905125 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 102 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 9 states.
The verdict
NCT00905125, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 9
- Study locations
Study Summary
In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman's immune response (the body's defense against the flu) after getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this US based study. Participation will be about 8 months in duration. Women will be randomized (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on Day 0 and 28 days post vaccination.
Conditions Studied
Interventions
- BIOLOGICAL Fluzone®
- BIOLOGICAL Fluarix®
Study Locations (9)
Georgia
- Emory University School of Medicine - Gynecology and Obstetrics - Atlanta
Iowa
- University of Iowa - Iowa City
Maryland
- University of Maryland Baltimore - Baltimore
Minnesota
- Mayo Clinic, Rochester - Vaccine Research Group - Rochester
Missouri
- Saint Louis University - St Louis
North Carolina
- Duke University Medical Center - Durham
Tennessee
- Vanderbilt University - Nashville
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00905125
The ClinicalTrials.gov registry entry for NCT00905125 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% 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 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone® is the first listed.
NCT00905125 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Georgia, Iowa, Maryland.
Frequently Asked Questions
What is clinical trial NCT00905125 about?
NCT00905125 is a clinical study titled "Influenza Vaccine in Pregnant Women". In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman'...
What is the current status of trial NCT00905125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2009-06. Estimated completion is 2010-03.
What conditions does trial NCT00905125 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00905125?
The interventions under investigation include: Fluzone® (BIOLOGICAL), Fluarix® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00905125?
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 NCT00905125 being conducted?
This trial has 9 study locations across Georgia, Iowa, Maryland, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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